FDA Unveils Plan for Draft CMC Guidance in 2019

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CDER Guidance in 2019: Lots of Procedural and Quality Documents Coming

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue new draft and revised draft quality/chemistry manufacturing and controls (CMC) guidance documents spanning different categories, from biosimilars to microbiology to Pharmaceutical Quality, in 2019.

In 2018, on the CMC front, new drafts on CMC postapproval manufacturing changes for specified biologics in annual reports, visual inspection of injectable drugs and in-vitro methods for the evaluation of abuse-deterrent properties of opioids were unveiled.

The bulk of the 2019 guidance documents are contained in two categories:  pharmaceutical quality/CMC and procedural.

Under the category of pharmaceutical quality/CMC, CDER is planning to issue guidance on risk management plans, the inspection of injectables for visible particulates, stability considerations and quality considerations for topical ophthalmic products, among others, as well as a revised draft guidance on drug master files (which was also on last year’s guidance list).

And under the category of procedural guidance, FDA is planning to issue documents on Rare Diseases: Common Issues in Drug Development.

Other notable guidance documents include one for biosimilars sponsors on comparative analytical assessments, which follows FDA’s decision last June to withdraw a draft guidance on biosimilar analytical studies. In addition, FDA is planning two revised draft guidance documents on pediatric product development, three-year exclusivity determinations for generic products and multiple guidance documents on post marketing studies and safety reporting.

The plan for 2019 draft guidance documents from the US Food and Drug Administration (FDA) includes more than 10 in the Pharmaceutical Quality/CMC categories.

Guidance Agenda

New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2019

CATEGORY – Biosimilars

  • Comparative Analytical Assessment to Support a Demonstration of Biosimilarity to a Therapeutic Protein Product

CATEGORY – Combination Products

  • Bridging for Drug-Device and Biologic-Device Combination Products

CATEGORY – Drug Development Tools

  • Qualification Process for Drug Development Tools

CATEGORY – Pharmaceutical Quality/Microbiology

  • Microbiological Considerations for Non-Sterile Drug Products Version: 01 March 2019

CATEGORY — Pharmaceutical Quality/CMC

  • CDER’s Program for the Recognition of Voluntary Consensus Standards
  • Drug Master Files; Revised Draft
  • 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
  • Transdermal and Topical Delivery Systems- Product Development and Quality Considerations
  • Quality Considerations for Continuous Manufacturing (CM)
  • Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software
  • Using the Inactive Ingredient Database
  • Risk Management Plans for Drug Manufacturers
  • Quality Considerations for Topical Ophthalmic Drug Products
  • Inspection of Injectable Products for Visible Particulates
  • Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biologics
  • Stability Considerations for NDAs, ANDAs and BLAs
  • ANDAs: Stability Testing of Drug Substances and Products Questions and Answers

CATEGORY – Rare Diseases

  • Rare Diseases: Common Issues in Drug Development

(See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for details about the Guidance Agenda.)

Note: Agenda items reflect draft and revised draft guidances under development as of the date of this posting.