Updates Spotlight!
Guidance DocumentsCVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications
This guidance clarifies the current approaches and recommendations for HUS assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval. CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
This guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. Considerations in Demonstrating Interchangeability With a Reference Product: Update
This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
This guidance finalizes the draft guidance of the same title issued on December 16, 2022 (87 FR 77125), and supersedes the October 2014 guidance entitled, “Circumstances that Constitute Delaying, Limiting, or Refusing a Drug Inspection”, which is withdrawn. Facility Readiness: Goal Date Decisions Under GDUFA
This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). Diabetic Foot Infections: Developing Drugs for Treatment
The FDA is announcing the availability of a final guidance for industry entitled “Diabetic Foot Infections: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint involvement. Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
This guidance provides recommendations to assist industry in the development of oligonucleotide therapeutics under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314. View all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period. ICYMI!Advisory Committees Give FDA Critical Advice and the Public a Voice
At the U.S. Food and Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best science available.
The FDA’s complex and multifaceted mission includes evaluating new medical devices and medicines, including vaccines and other therapies, to determine if they are safe and effective for their intended use. FDA advisory committees give our own agency experts outside, independent, and professional advice on various complex scientific, technical, and policy issues.
Advisory committee meetings can include a broad scientific discussion about important topics. They can also be more focused on a specific product under FDA review. Webinars and Virtual Workshops
FDA Grand Rounds - Salmonella and Escherichia coli: Challenges Along the One Health Continuum
July 11, 2024; Noon - 1:00 p.m. ET
The presentation will focus on Salmonella and Escherichia coli which are bacterial pathogens that infects humans and a wide range of other animal hosts where they have the potential to spread to across species creating One Health concerns. | FDA employees MUST register in BOTH the following: |
Non- FDA employees must register below: Webinar - In Vitro Diagnostic Product (IVD): Classification
July 16, 2024; 1:00 - 2:00 p.m. ET
On July 16, 2024, the FDA will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.
Registration is not required.
CVM Public Meeting: First Annual Animal Drug User Fee Educational Conference
July 17, 2024; 9:00 a.m. - 5:00 p.m. ET
On Wednesday, July 17, 2024, the FDA’s Center for Veterinary Medicine (CVM) will host the first of a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process. FDA Advances Health Equity: Home as a Health Care Hub
July 25, 2024; Noon to 4:00 p.m. ET
The FDA continues to advance the Home as a Health Care Hub initiative with new ways to share progress, answer questions, and receive feedback from stakeholders.
Today, the FDA is announcing a new web page and virtual public meeting dedicated to this health equity initiative. View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts About UsThe Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov. | 
