Posted 07 February 2022 | By Jeff Craven
About one-third of the guidance documents in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER)’s 2022 guidance agenda are new, with some recognizable documents from previous years making a reappearance.
CDER’s guidance agenda, which is widely understood to be a wish list for the center, contains hints about the center’s focus for the year. However, CDER makes it clear that the agenda is not a promise to publish all the listed guidance documents in a given year. In total, 98 guidances are planned for 2022, with 29 new documents, 1 revised document and 66 documents that are carryovers from last year appearing on the list. In contrast, 2020’s list contained 105 guidances, which included 42 new guidances and many existing guidance documents from the previous year. (RELATED: CDER lays out 2021 guidance agenda, Regulatory Focus 27 January 2021)
The list for 2022 includes one new category that didn’t appear last year: drug development tools. CDER has included a single guidance document on an evidentiary framework for biomarker qualification under that category. The center also says it plans to revise its draft guidance on how to report amounts of listed drugs and biologics.
Notable new guidances planned for 2022 include documents under the real-world data (RWD) and evidence category on use of RWD in randomized controlled trials to make regulatory decisions, guidance on how to design externally controlled trials. There are also plans to release four documents concerning over-the-counter (OTC) drugs specifically outlining how to format and organize data submissions for OTC monograph order requests, how to electronically submit these order requests electronically, what the formal meetings between FDA and OTC monograph drug sponsors will look like, and describing the formal dispute resolution procedure.
Other notable guidances include documents on deviations in protocol for clinical trials, implementation and use of Identification of Medicinal Products, data integrity for bioavailability and bioequivalence studies, and guidance documents concerning drug labeling.
The full list of what’s new, what’s carried over from previous CDER agendas, and what documents have been revised for 2022 is included at the bottom of this post.
| New CDER guidances for 2022 |
| Clinical/Antimicrobial |
| Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases |
| Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention |
| Clinical/Medical |
| Assessment of Pressor Effects of Drugs; Revised Draft |
| Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials |
| Protocol Deviations |
| Clinical Pharmacology |
| Clinical Pharmacology Considerations for Antibody-Drug Conjugates |
| Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics |
| Clinical Pharmacology Consideration for Human Mass Balance Studies |
| Compounding |
| Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act |
| Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act |
| Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application |
| Drug Development Tools |
| Biomarker Qualification: Evidentiary Framework |
| Electronic Submissions |
| Identification of Medicinal Products: Implementation and Use |
| Generics |
| ANDA and NDA Submissions: Data Integrity for BA/BE Studies at Testing Sites |
| Content and Format of Composition Tables in NDAs and ANDAs And Corresponding Formulation Labeling |
| “Open for Business” Definition Under 744B of the Federal Food, Drug and Cosmetic Act |
| Topical Dermatologic Corticosteroids: In Vivo Bioequivalence |
| Labeling |
| Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format; Revised Draft |
| Over-the-Counter Drugs |
| Formal Dispute Resolution and Consolidated Proceedings: Requestor of OMUFA Products Appeals Above the Division Level |
| Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
| OTC Monographs Order Requests (OMORs) – Format and Content of Data Submissions |
| Providing Regulatory Submissions in Electronic Format for Over-the-Counter Monograph Requests |
| Pharmaceutical Quality/CMC |
| Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens |
| Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products |
| Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs |
| Pharmacology/Toxicology |
| Use of Whole Slide Imaging (WSI) in Nonclinical Toxicology Studies: Questions and Answers |
| Procedural |
| Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers |
| Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug and Cosmetic Act; Revised Draft |
| Real-World Data/Real-World Evidence (RWD/RWE) |
| Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products |
| Using Clinical Practice Data in Randomized Controlled Trials (RCT) for Regulatory Decision-Making for Drug and Biological Products |
Source: https://www.raps.org/news-and-articles/news-articles/2022/2/cder-unveils-30-new-planned-guidance-documents-in