Life Science Compliance Update

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March 31, 2017

CDER 2017 Guidance Agenda

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In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017 calendar year. CDER’s 102-part agenda is organized by category and touches on a variety of topics, giving us a glimpse of what to expect throughout the year. This year’s agenda follows a similar pattern to the Center’s 2016 agenda, placing an emphasis on the clinical aspects of drug development, pharmaceutical quality, generics, and procedural activities. However, CDER is not bound by this list of topics, required to issue a guidance on every topic included in the list, or precluded from developing guidance on topics not included in the list. According to Regulatory Focus, several items on the 2017 list were also listed in 2016.

Delayed by Trump Executive Order?

Maybe, but it is not entirely clear. Additionally, the items in CDER’s announcement reflect only draft and revised draft guidances under development as of the date of FDA's posting. So there is still the potential for modifications, even more potential guidances.

Recent reporting from Regulatory Focus indicates the “Two Out, One In” Executive Order may have been clarified through OMB guidance to offer “wiggle room” for the FDA in issuing guidances. OMB notes that “significant guidance or interpretive documents will be addressed on a case-by-case basis.” Rachel Sachs, an associate law professor at Washington University in St. Louis, argues the OMB document "significantly restricts" and "walks back" the reach of the EO because it exempts classes of regulations required by law and appreciates that regulations may be deregulatory in nature so the costs and issuance of such regulations will be considered accordingly.

“Emergencies addressing critical health, safety, or financial matters, or for some other compelling reason, may qualify for a waiver from some or all of the requirements of Section 2,” the guidance also notes, which may further allow the FDA room to move on these issues.

The 2017 Agenda

A few interesting items that stood out:

Advertising:

  • Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities

Biopharmaceutics:

  • Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations; Revised Draft

Biosimilarity:

  • Considerations in Demonstrating Interchangeability With a Reference Product
  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Clinical/Medical:

  • Guidance for clinical Investigators and Sponsors Natural History Studies for Rare Disease Drug Development
  • Pediatric Oncology Product Development; Revised Draft
  • Rare Diseases: Drug Development Safety Data Considerations

Clinical Pharmacology:

  • Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations, Revised Draft
  • Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling; Revised Draft
  • Exposure-Response Relationships – Study Design, Data Analysis, and Regulatory Applications; Revised Draft
  • Population Pharmacokinetics; Revised Draft

Clinical/Statistical:

  • Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft
  • Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

Drug Safety:

  • Format and Content of a REMS Document, Revised Draft
  • Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft

Electronic Submissions:

  • 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

Generics:

  • 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
  • Controlled Correspondence Related to Generic Drug Development; Revised Draft
  • 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
  • Meetings With Applicants of Complex Generic Drug Products
  • Pre Submission Facility Correspondence for Priority ANDAs in GDUFA II
  • Three-Year Exclusivity Determinations for Drug Products
  • Variations in Drug Products (ANDAs) Guidance

Labeling:

  • Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format

Pharmaceutical Quality/CMC:

  • GDUFA II Priority ANDA Pre-Submission Communications
  • Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process

Pharmaceutical Quality/Manufacturing Standards (CGMP):

  • Current Good Manufacturing Practice for Medical Gases; Revised Draft
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft

Procedural:

  • Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers
  • Civil Monetary Penalties for Failure to Meet Accelerated Post marketing Requirements
  • Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
  • Content of Human Factors Submissions for Evaluation
  • Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification
  • Enforcement Policy Regarding Ingredients Nominated for Inclusion on the Bulk Drug Substances List Pursuant to Section 503B
  • Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
  • National Drug Code (NDC) Assignment of CDER-Regulated Products
  • Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft
  • Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft
  • Public Disclosure of FDA-Sponsored Studies
  • Refuse to File: NDA and BLA Submissions
  • REMS Assessment: Planning and Reporting
  • Standardization of Data and Documentation Practices for Product Tracing
  • Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
  • Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
  • Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

User Fees:

  • User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
  • Fees Incurred Under the Drug Supply Chain Security Act

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