The agency plans on publishing more than 100 new or revised guidance documents in 2017.
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 The list includes new and revised draft guidance documents with topics ranging from biopharmaceutics to clinical, to quality, to labeling, and more.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.