FDA Releases 2017 Guidance Agenda

On January 11, 2017, FDA released the Center for Drug Evaluation and Research’s (CDER) guidance agenda for 2017, which includes more than 100 guidance documents to be published this year. The list includes new and revised draft guidance documents with topics ranging from biopharmaceutics to clinical, to quality, to labeling, and more.

Of the guidance documents CDER plans on publishing, pharmaceutical manufacturers may be most interested in the following:

• Format and Content of a REMS Document, Revised Draft

• Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft

• Restricted Delivery Systems: Flow Restrictors and Oral Liquid Drug Products

• Standardized Format for Electronic Submissions of NDA and BLA Content and Planning and Conduct of Bioresearch Monitoring Inspections for Submissions to CDER

• Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information

• Providing Regulatory Submissions in Electronic Format–Bioanalytical Methods Data Standards

• Providing Regulatory Submissions in Electronic Format–Standardized Bioanalytical Data

• Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft

• Drug Master Files; Revised Draft

• Drug Products, Including Biological Products, That Contain Nanomaterials

• Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process

• In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products.

A few of the guidance documents that biopharma manufacturers may specifically be interested in include the following:

• Considerations in Demonstrating Interchangeability with a Reference Product

• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

• CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports.

Generic-drug manufacturers may want to look out for the following:

• 180-Day Exclusivity: Questions and Answers

• ANDA Submissions–Amendments to Abbreviated New Drug Applications Under GDUFA

• ANDA Submissions–Content and Format of Abbreviated New Drug Applications; Revised Draft

• ANDA Submissions Refuse to Receive Standards: Questions and Answers

• Changes That May Be Included in a Single Prior Approval Supplement for an ANDA

• Determining Whether to Submit an Application Under 505(b)(2) or 505(j)

• Issuance of ANDA Complete Response Letters Before Completion of Review by One or More Disciplines

• Pre Submission Facility Correspondence for Priority ANDAs in GDUFA II

• Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Reference Peptide Drug Products of rNDA Origin

• Three-Year Exclusivity Determinations for Drug Products

• Variations in Drug Products (ANDAs) Guidance

Additional planned guidance documents include those on labeling, quality, post-approval changes, packaging, and user fees.

Source: FDA