CDER Small Business Update: New Guidance Documents and Federal Register Notices

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

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1. Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)

  

This guidance provides answers to anticipated questions from generic drug industry participants regarding the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) (Public Law 112-144, Title III), commonly referred to as GDUFA. The questions and answers (Q&A) format is intended to promote transparency and facilitate compliance. The first version of this document was issued pursuant to 21 CFR 10.115 and was made available on FDA’s website on August 22, 2012.

FDA is revising this draft guidance. The revision clarifies some of the questions and answers included in the first version and adds several new questions and answers that have arisen since the launch of the program, including questions FDA received following issuance of the first draft of the guidance.

Federal Register

Guidance Document

 

2. Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration

 

This guidance specifies the unique facility identifier (UFI) system for registration of domestic and foreign drug establishments. This guidance is intended to address provisions set forth in section 510 of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), regarding the specification of the UFI system.

Federal Register

Guidance Document

3. Fee for Using a Priority Review Voucher in Fiscal Year 2014

FDA is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Amendments Act of 2007, authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2014.

Federal Register

 

4. Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate

FDA is announcing the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate; salmeterol xinafoate.

Federal Register

Guidance Document

5. Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability

FDA is announcing the availability of a guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” The guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and IRBs in determining whether human research studies must be conducted under an IND. The guidance describes the basic criteria for determining when an IND is required, describes specific situations in which an IND is not required, and addresses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.

Federal Register