FDA Releases Agenda for New & Revised Guidances for Year 2017

In its Agenda Centre for Drug Evaluation and Research (CDER) is Planning to Published New & Revised Draft Guidances during Calendar Year 2017.

In FDA Agenda, there are total list of more than 100 New & Revised Draft Guidances from 16 different categories including Biopharmaceutics, Clinical Pharmacology, Drug Safety, Electronic Submissions, Generics-ANDA, Labeling, CMC , Procedural and more which CDER is planning to publish in year 2017.
Here is the summary of New & Revised Draft Guidances for 2017

CATEGORY Number of Guidences
Advertising 1
Biopharmaceutics 3
Biosimilarity 2
Clinical/Antimicrobial 1
Clinical/Medical 11
Clinical Pharmacology 8
Clinical/Statistical 3
Drug Safety 3
Electronic Submissions 4
Generics 13
Labeling 6
Pharmaceutical Quality/CMC 11
Pharmaceutical Quality/Manufacturing Standards (CGMP) 4
Pharmacology/Toxicology 1
Procedural 29
User Fees 2


Maximum guidance’s FDA is planning to publish are from Procedural category (29) are listed below:

  1. Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers
  2. Civil Monetary Penalties for Failure to Meet Accelerated Post marketing Requirements
  3. Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
  4. Content of Human Factors Submissions for Evaluation
  5. Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification
  6. Drug Products Labeled as Homeopathic*
  7. Enforcement Policy Regarding Ingredients Nominated for Inclusion on the Bulk Drug Substances List Pursuant to Section 503B
  8. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
  9. Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles
  10. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
  11. Identifying Trading Partners Under the Drug Supply Chain Security Act
  12. Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
  13. National Drug Code (NDC) Assignment of CDER-Regulated Products
  14. Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft
  15. Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft
  16. Public Disclosure of FDA-Sponsored Studies
  17. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy
  18. Qualified Infectious Disease Product Designation: Questions and Answers
  19. Recommended Statement for Over-the-Counter Aspirin Containing Drug Products Labeled with Cardiovascular Related Imagery
  20. Refuse to File: NDA and BLA Submissions
  21. Regulatory Considerations: Complying with the Pediatric Research Equity Act (PREA) & Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals Act (BPCA); Revised Draft
  22. REMS Assessment: Planning and Reporting
  23. Standardization of Data and Documentation Practices for Product Tracing
  24. Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
  25. The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers
  26. Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
  27. Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
  28. Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
  29. Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act.

Generic category having the second maximum numbers of guidances which are listed below:

  1. 180-Day Exclusivity: Questions and Answers
  2. ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA
  3. ANDA Submissions – Content and Format of Abbreviated New Drug Applications; Revised Draft
  4. ANDA Submissions Refuse to Receive Standards: Questions and Answers
  5. Controlled Correspondence Related to Generic Drug Development; Revised Draft
  6. Changes That May Be Included in a Single Prior Approval Supplement for an ANDA
  7. Determining Whether To Submit an Application Under 505(b)(2) or 505(j)
  8. Issuance of ANDA Complete Response Letters Before Completion of Review by One or More Disciplines
  9. Meetings With Applicants of Complex Generic Drug Products
  10. Pre Submission Facility Correspondence for Priority ANDAs in GDUFA II
  11. Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Reference Peptide Drug Products of rNDA Origin
  12. Three-Year Exclusivity Determinations for Drug Products
  13. Variations in Drug Products (ANDAs) Guidance

Pharmaceutical Quality/CMC and Clinical/Medical category categories both having the list of 11 guidences each

Pharmaceutical Quality/CMC:

  1. CMC Post-approval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports
  2. Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft
  3. Drug Master Files; Revised Draft
  4. Drug Products, Including Biological Products, That Contain Nano materials
  5. GDUFA II Priority ANDA Pre-Submission Communications
  6. Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
  7. In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
  8. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft
  9. Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software
  10. Use of the FDA Inactive Ingredient Software (IID)
  11. Visual Inspection of Injectable Drug Products


Refer complete list of guidences from all categories

Source: US FDA

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