A look at what remains on FDA’s 2022 guidance agendas


Oct. 13, 2022

With just 81 days to go in the calendar year, four of the FDA’s major review centers – CDER, CBER, CDRH and CFSAN – have between them 102 guidance documents that they planned to publish in 2022. In this analysis, AgencyIQ explains the ins and outs of FDA’s guidance agendas, including the documents we might see by year’s end – or on next year’s agendas.

With less than 3 months left in the 2022 calendar year – just 81 days as this article is published – there are dozens of guidance documents remaining on the FDA’s various “guidance agendas,” according to a review by AgencyIQ.

First, let’s explain what a guidance agenda is.

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.45, the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” This list is known as the FDA’s “guidance agenda,” and in practice details the documents that FDA plans to release to the public, and not simply develop.

However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center. These documents, though similar, do differ in several important respects. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), for example, publish agendas applicable to its calendar year. FDA’s Center for Devices and Radiological Health, meanwhile, publishes in accordance with the government’s fiscal year. CDER only releases a list of topics for which it is working to develop draft guidance, while CBER and CDRH specify the status of development (draft, revised draft or final).

There are other key differences as well. CBER and CDRH tend to publish relatively modest (but more attainable) development agendas, whereas CDER’s agenda is extensive but is rarely even a third complete by year’s end (although CDER also publishes more guidance than all other centers combined). Finally, while the FDA is required to publish its guidance agendas, these documents are often updated at least once during the course of the year to add new documents or to reflect that some documents have been published.

High-level findings

Now let’s look at what the FDA had planned for 2022 (or in CDRH’s case, for FY2022, which ended October 1).

Between the FDA’s three major product review centers – CBER, CDER and CDRH – the agency planned to release 158 guidance documents in 2022. FDA’s Center for Food Safety and Applied Nutrition (CFSAN), which regulates food products, also said it intended to release two dietary supplement-related documents, for a total of 160 guidance documents.

Status of guidance documents included in guidance agendas, by FDA review center

  Guidance Published Guidance Not Yet Published Percentage of Guidance Agenda Published
CDER 34 83 29%
CDRH 14 9 60%
CBER 9 9 50%
CFSAN* 1 1 50%
Total 58 102 36%

*Only reflects CFSAN’s two dietary supplement-related guidance documents. There are 26 total documents on its CY2022 guidance agenda.

As of October 12, 2022 the FDA four centers (CDER, CBER, CDRH and CFSAN) have released 58 guidance documents that were planned for release as part of their guidance agendas. However, there are an additional 102 guidance documents that were planned for release but that have not yet been published in either draft or final form. This equates to 36% of all documents planned for release in 2022.

What remains unpublished, and what’s next

So, what hasn’t yet made the “published” list, and what might we see in the remaining weeks of the calendar year?

AgencyIQ has gone through FDA’s list of published guidance documents, as well as our own analyses, to determine which guidance documents haven’t yet seen the light of day. Read on to see which documents remain in development as of October 12, 2022.

As a quick aside, this list is likely to change within the next few weeks. Because CDRH publishes according to a fiscal year basis, it has been in the habit of releasing its guidance agenda shortly after the start of the fiscal year, which began October 1, 2022. In FY2022 (October 1, 2021 through September 30, 2022), for example, it updated its guidance agenda on October 26, 2021. We’ll be sure to make note of that new agenda for our subscribers once it’s published.

But that being said, do not expect FDA to publish 102 guidance documents between now and December 31. A guidance document that is not released in a given year is most often recycled into next year’s guidance agenda, unless the agency has truly ceased development due to previously unforeseen circumstances or changes.

What can we expect the FDA to do in the remainder of CY2022? Let’s do some back-of-the-envelope math to develop an estimate. In FY2022, FDA released an average of 13.75 guidance documents per month related to medical product regulation and dietary supplements (i.e., excluding food, veterinary and tobacco products). With 247 work days in FY2022 (excluding weekends and holidays), the FDA published one guidance every 1.5 work days, on average.

With just 52 work days left in CY2022, we can therefore expect the FDA to publish approximately 34 additional guidance documents before January 1, 2023. Of course, there are other factors to consider, such as typical slowdowns around the holidays. But if we had to guess, we’re likely to see somewhere between 25-30 guidance documents before the end of the year.

Unpublished guidance, by FDA center:

Center for Biologics Evaluation and Research

Guidance Title Type (Draft/Final)
Alternative Procedures for Cold-Stored Platelets Intended for Transfusion Draft
Collection of Platelets by Automated Methods Draft
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Final
Human Gene Therapy for Neurodegenerative Diseases Draft
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide Final
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products Draft
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial Final
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies Final

Center for Devices and Radiological Health

Guidance Title Type (Draft/Final)
Remanufacturing of Medical Devices Final
Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) Draft
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers Draft
Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care Draft
Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder Draft
Questions & Answers Regarding Certificates for Devices Not Exported from the United States (CDNE) Draft
Content of Human Factors Information in Medical Device Marketing Submissions Draft
Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft
Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations Draft

Center for Drug Evaluation and Research

Guidance Title Type (Draft/Final)
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment Draft
Product Class-Specific Recommendations for Developing Biosimilar and Interchangeable Biological Products Draft
Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention Draft
Pulmonary Tuberculosis: Developing Drugs for Treatment Draft
Chronic Pain: Developing Drugs for Treatment Draft
Decentralized Clinical Trials Draft
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development Draft
Local Anesthetic Drug Products: Extended-Release Formulation Development and Labeling Considerations Draft
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials Draft
Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence Draft
Migraine: Developing Drugs for Preventive Treatment Draft
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Draft
Protocol Deviations Draft
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations Draft
Use of Data Monitoring Committees in Controlled Clinical Trials Draft
Exposure Response Relationships Draft
Pharmacogenomic Data Submission Draft
Clinical Pharmacology Considerations for Peptides Draft
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Revised Draft
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Revised Draft
Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Draft
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act Draft
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Draft
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Draft
Biomarker Qualification: Evidentiary Framework Draft
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act Draft
Identification of Medicinal Products: Implementation and Use Draft
NDC Assignment of Human Drugs including Biological Products Draft
Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards Draft
Group Purchasing Organization vs. Private Label Distributor Draft
Repackagers and Relabelers of Human Drugs: Labeling; Registration and Listing, Safety Reporting, Supply Chain Security, and Good Manufacturing Practice Draft
180-Day Exclusivity: Questions and Answers Revised Draft
ANDA and NDA Submissions: Data Integrity for BA/BE Studies at Testing Sites Draft
ANDA Submissions – Refuse-to-Receive for DMF Facilities Deficiencies Draft
ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers Draft
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Revised Draft
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications Revised Draft
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Revised Draft
Content and Format of Composition Tables in NDAs and ANDAs And Corresponding Formulation Labeling Draft
Controlled Correspondence Related to Generic Drug Development Revised Draft
Handling and Retention of BA and BE Testing Samples Draft
Impact of Court Orders on 30 month Stay of Approval Draft
In Vitro Permeation Tests for Semisolid Topical Products Submitted in ANDAs Draft
In Vitro Release Tests for Semisolid Topical Products Submitted in ANDAs Draft
“Open for Business” Definition Under 744B of the Federal Food, Drug and Cosmetic Act Draft
Pediatric Exclusivity General Considerations for ANDAs Draft
Physico-Structural (Q3) Characterization of Topical Dermatological Drug Products Submitted in ANDAs Draft
Product Specific Guidance Meetings Between FDA and ANDA Applicants under GDUFA Draft
Sameness Evaluations in an ANDA – Active Ingredients Draft
Statistical Approaches to Establishing Bioequivalence Draft
Three-Year Exclusivity Determinations for Drug Products Draft
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Draft
Combined Hormonal Contraceptives for Prevention of Pregnancy — Labeling for Health Care Providers and Patients Draft
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Revised Draft
Labeling for Biosimilar and Interchangeable Biosimilar Products Draft
Regulatory Considerations and Drug Labeling Recommendations for Prescription Drug Use-Related Software for Combination Products Draft
Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products Draft
Formal Dispute Resolution and Consolidated Proceedings: Requestor of OMUFA Products Appeals Above the Division Level Draft
OTC Monographs Order Requests (OMORs) – Format and Content of Data Submissions Draft
PET Drugs – Current Good Manufacturing Practice (CGMP) Revised Draft
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens Draft
Quality Considerations for Topical Ophthalmic Drug Products Draft
Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products Draft
Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs Draft
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions Guidance for Industry Draft
Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Draft
Exclusivity for First Interchangeable Biosimilar Biological Products Draft
Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers Draft
Fixed Dose Combinations and Single-Entity Versions of Previously Approved Draft
Antiretrovirals for the Treatment of Human Immunodeficiency Virus-1 Under President’s Emergency Plan for AIDS Relief (PEPFAR) Draft
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act Draft
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Draft
Key Information and Facilitating Understanding in Informed Consent for FDA-Regulated Clinical Investigations Draft
Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations Revised Draft
Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations Revised Draft
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug and Cosmetic Act Revised Draft
Responding to CGMP Observations on Form FDA 483  
Tropical Priority Review Vouchers Draft
Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Draft
Wholesale Distributor Verification Requirements for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policy Draft
351(k) BLA Supplement Classification Categories Draft
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Draft
Using Clinical Practice Data in Randomized Controlled Trials (RCT) for Regulatory Decision-Making for Drug and Biological Products Draft

Center for Food Safety and Applied Nutrition

Guidance Title Type (Draft/Final)
New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry Draft

To contact the author of this analysis, please email Alec Gaffney ([email protected])

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