As we approach June, companies should be reviewing their records to ensure updates to any NDC listings that have had changes in the past 5 months. There are two periods during the year in which NDC listings should be updated: June and the renewal period from Oct – Dec. If no edits are needed to an NDC listing during a calendar year, a certification must be submitted during the renewal period to indicate to the agency that the SPL file has been reviewed and remains accurate. The FDA uses this data for reconciling records and ensuring that CARES volume reports have been submitted for active NDC listings. Allowing a listing to lapse does not constitute delisting. A marketing end date file must be submitted to finalize the listing with the agency. The FDA is now publishing lists of facilities that have both Active and Inactive listings that have not submitted CARES volume reports. If your company has listings identified on the Inactive List, the agency is still expecting a CARES volume report. You must submit a marketing end date for these SPL files to remove them from the database requiring a CARES report. You can check the Companies that Have Not Submitted Drug Amount Reports website for these lists.
The FDA has launched a One-Day Inspectional Assessments pilot as part of their ongoing surveillance program. These shorter, focused screening assessments are designed to broaden coverage and allow for more surveillance inspections to be conducted. These targeted assessments will be a new tool for risk assessment. It is hoped the information gathered from these inspections will help the agency with future oversight activities. Flexibility allows the agency to expand the assessments beyond one day should conditions warrant. This approach will not be applicable to high risk or complex facility operations. Evaluation metrics are being designed to assess the effectiveness of the pilot program. See the website for full details.
Highlighted Guidance Documents
Statistical Approaches to Establishing Bioequivalence
The FDA is announcing the availability of a final guidance for industry titled “Statistical Approaches to Establishing Bioequivalence.” This guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence studies for investigational new drug applications, new drug applications, abbreviated new drug applications, and amendments and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
The FDA is announcing the availability of a final guidance for industry titled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” This guidance provides recommendations to applicants planning to include bioequivalence information in abbreviated new drug applications, ANDA amendments, and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act and FDA regulations. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021
Postapproval Pregnancy Safety Studies
The FDA is announcing the availability of the final guidance for industry titled “Postapproval Pregnancy Safety Studies.” The purpose of this guidance is to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA (i.e., pregnancy safety studies) in the postapproval setting. This guidance finalizes the draft guidance of the same name issued on May 9, 2019.
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application
This guidance describes how FDA applies flexibility to the chemistry, manufacturing, and controls requirements for human cellular and gene therapy products being developed for biologics license applications under 21 CFR 601. Consistent with the statutory and regulatory requirements for biological products, FDA uses a flexible approach to ensuring applicable CMC requirements are met for CGT products. FDA’s flexible approach serves to help expedite development, review, and patient access to safe and effective CGT products to treat serious or life-threatening conditions that represent significant unmet medical needs.
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
This guidance provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products under investigational new drug applications to support new drug applications and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act. This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002).
DRAFT Establishing Impurity Specifications for Antibiotics
Submit Comments by 06/22/2026
All Guidance Documents can be searched on the FDA’s website.
Federal Register
- FR Vol 91, No. 81 Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana From Schedule I to Schedule III; Corresponding Change to Permit Requirements
- FR Vol 91, No. 81 Schedules of Controlled Substances: Rescheduling of Marijuana
- FR Vol 91, No. 81 Schedules of Controlled Substances: Rescheduling of Marijuana; Withdrawal
Meetings
Date: June 2 – 4, 2026
Time: 8:30 a.m. – 5:15 p.m. ET
Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
Date: June 4, 2026
Time: 1:00 p.m. – 4:00 p.m. ET
Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations
Date: June 11, 2026
Time: 8:30 a.m. – 12:30 p.m. ET
Date: June 24, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds
Date: August 25, 2026
Time: 10:00 a.m. – 4:30 p.m. ET
Location:
Attend In Person or Online
Virtual: via webcast
In Person: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503
Silver Spring, MD 20993
Navigating the GLP-1 Generic Drug Pathway (virtual)
Dates: September 23-24, 20216
Time: 8 AM-5:30 PM
FDA Websites of Interest
- FDA Advances Drug Repurposing to Address Unmet Medical Needs
- FDA Announces Major Steps to Implement Real-Time Clinical Trials
- FDA Expands AI Capabilities and Completes Data Platform Consolidation
- FDA is requesting comments on Regulations.gov for the following dockets, comment deadlines are noted:
- FDA-2026-N-3499 Obesity and Drug Dosing: Clinical Pharmacology Considerations (Jun 30, 2026)
- FDA-2026-N-3947 Impacts of Patient-Focused Drug Development Meetings (June 30, 2026)
- FDA-2026-N-4268 Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff (Jun 30, 2026)
- FDA-2026-N-4492 Drug Repurposing for Unmet Medical Needs (Jun 11, 2026)
- FDA-2023-C-5679 Color Additive Petition submitted seeking amended color additive regulations to remove FDA’s approval of three carcinogenic solvents (Jun 29, 2026)
Posted in Drug and Device Corner, Drugs, Medical Devices.