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THE GMP GAZETTETM

Jan 2015

CANADA (HEALTH CANADA) HPFBI

Internationally Harmonized Requirements for Batch Certification Content of the Fabricator's/Manufacturer's Batch Certificate for Drug/Medicinal Products (Content of the Batch Certificate for Medicinal Products) Exported to Countries under the Scope of a Mutual Recognition Agreement (MRA) Who’s affected? Fabricators and importers of marketed and investigational medicinal products who ship under the scope of a MRA The posted information supersedes the information currently available in Appendix A and A1 of GUI-0001, and includes, in part:

Batch Certificate content requirements which are also applicable to: o Non-finished medicinal products (intermediates, bulk, and partially packed products) o Investigational medicinal products (IMPs)

Batch Certificate content explanations revised to include: o Addition of IMP information to points 1, 3, 4 and 14 o The option of using EudraGMP reference numbers for point 11 o Additional Glossary entries

What’s the impact? Stakeholders must ensure that Batch Certificates issued or received meet the requirements Posting date: December 4, 2014

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NNHPD

NHPs Consultation - Revised Labelling Standard (Topical Anaesthetic, Analgesic, Antipruritic) The following Labelling Standard has been revised:

Topical Anaesthetic / Analgesic / Antipruritic

Guidance Document, The Guidance for Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard:

Outlines market authorization requirements for topical anaesthetics, analgesics and antipruritic products used to temporarily relieve pain and

itching

Does not apply to products that are for use on mucous membranes or surrounding areas

Who’s affected? All potential applicants wishing to submit NHP/drug applications for the above products The NNHPD is seeking comments from industry on the proposed Labelling Standard from December 19, 2014, to February 19, 2015. The information is available at the above web-links. What’s the impact? Potential applicants should review the upcoming changes. Once the Labelling Standard is finalized, applicants may either use the new Labelling Standard or submit references to support the safety and efficacy outside of the scope of the Labelling Standard. Posting date: December 19, 2014

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Consultation - Revised Monograph (Hydrocortisone - Topical) The monograph has been revised:

Hydrocortisone - Topical – December 30, 2014

Who’s affected? All potential applicants wishing to submit NHP applications that include the above ingredient The NNHPD is seeking comments from industry on the proposed monograph from December 29, 2014, to January 27, 2015. The information is available at the above web-link. What’s the impact? Potential applicants should review the upcoming changes. Once the monograph is finalized, applicants may either use the new monograph or submit references to support the safety and efficacy outside of the scope of the monograph. Posting date: December 29, 2014

DISINFECTANTS Consultation – Revised Monograph (Hard Surface Disinfectants Monograph) The monograph has been revised:

Hard Surface Disinfectants Monograph – January 7, 2015

Who’s affected? All potential applicants wishing to submit drug applications that include drug ingredients listed in the revised monograph

The NNHPD is seeking comments from industry on the proposed monograph from January 27, 2015 to February 6, 2015. The information is available at the above web-link.

The NNHPD intends to combine the existing Hard Surface Disinfectant monograph (February 2014) and the Toilet Bowl Disinfectant Cleaners (February

2014) monograph into a single Hard Surface Disinfectants Monograph.

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Applicants may add additional information to their product labels, outside of what is specified in the monograph. The additional information (e.g. non-

therapeutic claims) must not be false, misleading or likely to create an inaccurate impression of the product. In addition, the information must be

consistent with the labelling recommendations outlined in the following Guidance Documents:

Disinfectant Drugs

Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs What’s the impact? Potential applicants should review the upcoming changes and consult the Management of Disinfectant Drug Applications, Disinfectant Drugs and Safety and Efficacy Requirements for Hard Surface Disinfectant Drugs Guidance Documents. Applicants should also consult section 2.4 of the Guidance Document – Disinfectant Drugs to obtain information about the labelling requirements for disinfectant products. Once the monograph is finalized, applicants may either use the new monograph or submit references to support the safety and efficacy outside of the scope of the monograph. Posting date: January 7, 2015

NON-PRESCRIPTION DRUGS Consultation - Revised Labelling Standard (Topical Anaesthetic, Analgesic, Antipruritic) The following Labelling Standard has been revised:

Topical Anaesthetic / Analgesic / Antipruritic

Guidance Document, Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard:

Outlines market authorization requirements for topical anaesthetics, analgesics and antipruritic products used to temporarily relieve pain and

itching

Does not apply to products that are for use on mucous membranes or surrounding areas

Who’s affected? All potential applicants wishing to submit NHP/drug applications for the above products The NNHPD is seeking comments from industry on the proposed Labelling Standard from December 19, 2014 to February 19, 2015. The information is available at the above web-link.

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What’s the impact? Potential applicants should review the upcoming changes. Once the Labelling Standard is finalized, applicants may either use the new Labelling Standard or submit references to support the safety and efficacy outside of the scope of the Labelling Standard. Posting date: December 19, 2014

TPD

COSMETICS No updates

DRUGS Consultation on the Draft Guidance Document: Tamper-resistant Formulations of Opioid Drug Product Submissions In recent years, the Therapeutic Products Directorate (TPD) has seen a steady increase in the number of drug submissions received for opioid drugs with tamper-resistant formulations. This document is intended to provide guidance to sponsors seeking a Notice of Compliance (NOC) for their tamper-resistant controlled-release opioid products. It also provides information on what evidence is required to demonstrate tamper-resistance of the product to support a drug submission under the Food and Drug Regulations. The TPD is seeking comments from industry on the draft Guidance Document from December 22, 2014 to March 7, 2015. Who’s affected? Stakeholders seeking a NOC for a tamper-resistant controlled release opioid product. What’s the impact?

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The Guidance Document will help sponsors prepare their applications for tamper-resistant controlled release opioid products that are compliant with Health Canada requirements. Posting date: December 22, 2014

Notice - Release of draft Part I: Health Professional Information and Part II: Scientific Information - Guidance Document: Product Monograph Who’s affected? Pharmaceutical industry and Health care professionals. Consultation is now open on the draft for Part 1 and Part II of the Product monograph. Comments can be made from December 19, 2014 until March 4, 2015. Health Canada welcomes your comments on these proposed changes; particularly any comments you have on the following topics:

Restriction on the reference section

More clarity on comparator data expectations

More clarity on adverse reactions

More specificity with respect to pediatric data

Streamlining toxicology

Streamlining pharmacology

Rearranging the placement of certain information

General plain language improvements

General editorial improvements What’s the impact? The proposed revisions to Parts I and II of the Product Monograph will not only make health professional information in the Product Monograph easier to read, but also make critical safety information easier to find. This is a key aspect of plain language labelling. Posting Date: December 19, 2014

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MEDICAL DEVICES No updates

USA (FDA) CDER

DRUGS Guidance for Industry, Pharmaceutical Quality/CMC, SUPAC: Manufacturing Equipment Addendum Who’s affected? Drug product manufacturers who are preparing FDA submissions for manufacturing equipment changes This guidance:

Combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, and (2) SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum.

Should be used in conjunction with the following SUPAC guidances for industry: (1) Immediate Release Solid Oral Dosage Forms - Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, (2) SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, and (3) SUPAC-SS: Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation.

Contains general information on SUPAC equipment and no longer includes tables referencing specific equipment

Clarifies the types of processes being referenced

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What’s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: December 1, 2014

Draft Guidance for Industry, Labeling, Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products -Content and Format Who’s affected? Applicants submitting new drug applications (NDAs), efficacy supplements to approved NDAs, biologics license applications (BLAs) (for biological products that are regulated as drugs), and efficacy supplements to BLAs. This draft guidance:

Assists applicants in complying with new content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products (as described in the final rule published concurrently with this draft guidance)

Provides information for preparing subsections 8.1 Pregnancy, 8.2 Lactation, and 8.3 Females and Males of Reproductive Potential of the USE IN SPECIFIC POPULATIONS section of the full prescribing information (FPI) described in 21 CFR 201.56(d)(1) and 201.57(c)(9)(i) through (iii).

Includes an implementation plan that applies to previously submitted applications What’s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by February 2, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: December 4, 2014

Draft Guidance for Industry, Generics, How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD Who’s affected? Prospective applicants of abbreviated new drug applications (ANDAs)

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This draft guidance:

Describes how a prospective applicant may request a letter stating that FDA has determined: o That an applicable bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and

mitigation strategy (REMS) of the reference listed drug (RLD), and o FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic

firm/ agent to allow the firm to perform the testing necessary to support its ANDA What’s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by February 3, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: December 3, 2014

Guidance for Industry, Labeling, Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products Who’s affected? Applicants preparing submissions for human prescription drugs and biological products This guidance:

Is intended to assist applicants with the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18), including o How to decide what topics to include in the section o How to present the information o How to organize the section

What’s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: December 9, 2014

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Guidance for Industry, Electronic Submissions, Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act Who’s affected? Applicants planning to submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to CDER or CBER This guidance:

Indicates that FDA has concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by section 745A(a) in one guidance document.

Describes how FDA interprets and plans to implement the requirements of section 745A(a), while individual guidances will be developed and periodically issued to specify the formats for specific submissions and corresponding timetables for implementation.

Discusses: o The submission types that must be submitted electronically, o Exemptions from and criteria for waivers of the electronic submission requirements, and o The timetable and process for implementing the requirements.

What’s the impact? Congress granted explicit statutory authorization to FDA in Section 745A(a) of the FD&C Act to specify in guidance the format for the electronic submissions required under this section; therefore, this guidance contains binding provisions. Stakeholders need to be aware of the periodic issuance of further electronic submission guidances. Issued date: December 17, 2014

Guidance for Industry, Electronic Submissions, Providing Submissions in Electronic Format -- Standardized Study Data Who’s affected? Applicants planning to submit standardized clinical and nonclinical study data for NDAs, ANDAs, BLAs and INDs to CDER or CBER This guidance, and the technical specifications documents it references:

Describes the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act

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o The Agency can process, review, and archive electronic submissions that use the standards specified in the Data Standards Catalog posted to the FDA’s Study Data Standards Resources Web page

o For NDA, ANDA, and certain BLA submissions, all studies with a start date 24 months after the publication date of this guidance must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog

o For certain IND submissions, studies with a start date 36 months after the publication of this guidance must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog

What’s the impact? This guidance contains binding provisions. Study data must be submitted electronically in a format that FDA can process, review, and archive. If not, submissions will not be filed or received, unless exempted from the requirements as outlined in the guidance. Published in Federal Register date: December 18, 2014

Guidance for Industry, Procedural, DSCSA Implementation: Product Tracing Requirements — Compliance Policy Who’s affected? Trading partners (manufacturers, wholesale distributors, and repackagers) who must provide and capture certain product tracing information, as required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) This guidance:

Addresses the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the FD&C Act related to the exchange of product tracing information

Announces FDA’s intention with regard to enforcement of the product tracing information requirements o Requirements for the tracing of products through the pharmaceutical distribution supply chain go into effect on January 1, 2015, for

manufacturers, wholesale distributors, and repackagers o Due to the possibility of unforeseen complications with implementing the requirements that could cause disruptions in the supply

chain, impacting patients’ access to needed prescription drugs, FDA does not intend to take action, prior to May 1, 2015, against trading partners who do not provide or capture the product tracing information required by the Act

What’s the impact? This guidance is being implemented immediately. Stakeholders have an additional few months to implement the product tracing requirements. Issued date: December 23, 2014

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CBER VACCINES & BIOLOGICS Guidance for Industry & FDA Staff, Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex Who’s affected? Applicants planning to include a statement in medical product labeling indicating that natural rubber latex or synthetic derivatives of natural rubber latex were not used as manufacturing materials in the medical product, its container and/or packaging This guidance:

Applies to FDA regulated medical products (i.e., devices, drugs, biologics, and veterinary products) for which: o Natural rubber latex or synthetic derivatives of natural rubber latex were not used as materials in their manufacture; or o Any container and/or packaging was not made with natural rubber latex or synthetic derivatives of natural rubber latex.

Makes recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging

o FDA finds that the use of statements, such as “latex-free,” “does not contain latex,” or other similar labeling statements are, at this time, not scientifically supportable, and should not be used.

o FDA recommends the use of the statement “Not made with natural rubber latex”, or a variation of such. What’s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: December 2, 2014

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Draft Guidance for Industry, Labeling, Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products -Content and Format Who’s affected? Applicants submitting new drug applications (NDAs), efficacy supplements to approved NDAs, biologics license applications (BLAs) (for biological products that are regulated as drugs), and efficacy supplements to BLAs. This draft guidance:

Assists applicants in complying with new content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products (as described in the final rule published concurrently with this draft guidance)

Provides information for preparing subsections 8.1 Pregnancy, 8.2 Lactation, and 8.3 Females and Males of Reproductive Potential of the USE IN SPECIFIC POPULATIONS section of the full prescribing information (FPI) described in 21 CFR 201.56(d)(1) and 201.57(c)(9)(i) through (iii).

Includes an implementation plan that applies to previously submitted applications What’s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by February 2, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: December 4, 2014

Guidance for Industry, Labeling, Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products Who’s affected? Applicants preparing submissions for human prescription drugs and biological products This guidance:

Is intended to assist applicants with the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18), including o How to decide what topics to include in the section o How to present the information o How to organize the section

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What’s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: December 9, 2014

Guidance for Industry, Electronic Submissions, Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act Who’s affected? Applicants planning to submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to CDER or CBER This guidance:

Indicates that FDA has concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by section 745A(a) in one guidance document.

Describes how FDA interprets and plans to implement the requirements of section 745A(a), while individual guidances will be developed and periodically issued to specify the formats for specific submissions and corresponding timetables for implementation.

Discusses: o The submission types that must be submitted electronically, o Exemptions from and criteria for waivers of the electronic submission requirements, and o The timetable and process for implementing the requirements.

What’s the impact? Congress granted explicit statutory authorization to FDA in Section 745A(a) of the FD&C Act to specify in guidance the format for the electronic submissions required under this section; therefore, this guidance contains binding provisions. Stakeholders need to be aware of the periodic issuance of further electronic submission guidances. Issued date: December 17, 2014

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Guidance for Industry, Electronic Submissions, Providing Submissions in Electronic Format -- Standardized Study Data Who’s affected? Applicants planning to submit standardized clinical and nonclinical study data for NDAs, ANDAs, BLAs and INDs to CDER or CBER This guidance, and the technical specifications documents it references:

Describes the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act

o The Agency can process, review, and archive electronic submissions that use the standards specified in the Data Standards Catalog posted to the FDA’s Study Data Standards Resources Web page

o For NDA, ANDA, and certain BLA submissions, all studies with a start date 24 months after the publication date of this guidance must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog

o For certain IND submissions, studies with a start date 36 months after the publication of this guidance must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog

What’s the impact? This guidance contains binding provisions. Study data must be submitted electronically in a format that FDA can process, review, and archive. If not, submissions will not be filed or received, unless exempted from the requirements as outlined in the guidance. Published in Federal Register date: December 18, 2014

Draft guidance for Industry & FDA Staff, Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products Who’s affected? Manufacturers of human cells, tissues, and cellular and tissue-based product (HCT/P) This draft guidance:

Provides recommendations for meeting the criterion of minimal manipulation under 21 CFR 1271.10(a)(1)

Improves stakeholders’ understanding of the definitions of minimal manipulation in 21 CFR 1271.3(f), and how to apply the regulatory criterion in 21 CFR 1271.10(a)(1) to their HCT/Ps

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What’s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by February 23, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: December 23, 2014

Draft Guidance for Industry, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations Who’s affected? Sponsors, clinicians, and other establishments that manufacture and use HCT/Ps from adipose tissue This draft guidance:

Provides recommendations for complying with the regulatory requirements for HCT/Ps, as set forth in 21 CFR Part 1271, as established under the authority of the Public Health Service (PHS) Act, section 361

Provides recommendations for complying with section 351 of the PHS Act and the FD&C Act, and applicable regulations What’s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by February 23, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: December 23, 2014

Guidance for Industry, Procedural, DSCSA Implementation: Product Tracing Requirements — Compliance Policy Who’s affected? Trading partners (manufacturers, wholesale distributors, and repackagers) who must provide and capture certain product tracing information, as required under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) This guidance:

Addresses the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the FD&C Act related to the exchange of product tracing information

Announces FDA’s intention with regard to enforcement of the product tracing information requirements

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o Requirements for the tracing of products through the pharmaceutical distribution supply chain go into effect on January 1, 2015, for manufacturers, wholesale distributors, and repackagers

o Due to the possibility of unforeseen complications with implementing the requirements that could cause disruptions in the supply chain, impacting patients’ access to needed prescription drugs, FDA does not intend to take action prior to May 1, 2015 against trading partners who do not provide or capture the product tracing information required by the Act

What’s the impact? This guidance is being implemented immediately. Stakeholders have an additional few months to implement the product tracing requirements. Issued date: December 23, 2014

CFSAN

COSMETICS No updates

DIETARY SUPPLEMENTS No updates

CDRH

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MEDICAL DEVICES Guidance for Industry & FDA Staff, Infusion Pumps Total Product Life Cycle Who’s affected? Manufacturers of infusion pumps This guidance:

Assists in the preparation of premarket submissions for infusion pumps

Identifies device features that should be addressed throughout the total product life cycle

Provides recommendations that are intended to improve the quality of infusion pumps in order to reduce the number of recalls and adverse events associated with their use

Supersedes the “Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps,” issued March 1993 What’s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Issued date: December 2, 2014

Guidance for Industry & FDA Staff, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment Who’s affected? Applicants preparing a premarket approval application (PMA), Investigational Device Exemption (IDE), and premarket notification (510(k)) submission for passive implants (implanted devices that serve their function without the supply of electronic power) This guidance:

Addresses testing and labeling of passive implants for safety and compatibility in the MR environment

Supersedes Establishing Safety and Compatibility of Passive Implants in Magnetic Resonance (MR) Environment, August 21, 2008 What’s the impact? Contains non-binding recommendations unless specific regulatory or statutory requirements are cited. Stakeholders may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

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Issued date: December 11, 2014

Draft Guidance for Industry & FDA Staff, Radiation Biodosimetry Devices Who’s affected? Sponsors who intend to market radiation biodosimetry devices This draft guidance:

Describes design principles for studies that may be used to establish a reasonable assurance of the safety and effectiveness of radiation biodosimetry devices

o These studies are relevant for premarket notifications (e.g., 510(k) submissions or premarket approval applications (PMAs) that may be required for a particular device)

What’s the impact? For comment purposes only. Comments must be submitted either electronically or in writing to the FDA by March 30, 2015 to ensure the Agency considers them before beginning on the final version. Issued date: December 30, 2014

USP (GENERAL CHAPTERS) Proposed in Pharmacopeia Forum 40 (2)

Announcement to establish January 1, 2018 as the new date of applicability of the following general chapters:

<232> Elemental Impurities Limits

<2232> Elemental Contaminants in Dietary Supplements

Current general chapter <231> could be utilized or implement the new general chapters <232> / <2232> until January 1, 2018.

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As part of the implementation of <232> and <233>, USP will remove all references to general chapter Heavy Metals <231> from monographs and

general chapters in the USP-NF. The omission is scheduled for December 1, 2015 to align with the date of applicability of <232> and <2232>.

Posting date: January 14, 2015

Official date: January 1, 2018