FDA Issues Final Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species (MUMS)

The U.S. Food and Drug Administration has released updated information to help animal drug researchers and sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species (MUMS).

The final guidance, entitled, “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” was released as a draft guidance in July 2020 for public comment. The comment period was extended to 180 days in order to hear from all interested parties. The agency received many comments on the proposed Aquaculture Species Grouping section of the draft guidance; the agency intends to address aquaculture species grouping in greater detail in the future. Other revisions were made in response to public comments and to improve clarity.

 On Dec. 28, 2023, the FDA issued a new guidance to help drug manufacturers limit consumers’ and patients’ exposure to unacceptable levels of benzene in certain drug products. The guidance provides manufacturers with recommendations for testing and documentation related to reformulation of drug products that use carbomers manufactured with benzene, taking into consideration the various routes of administration and dosage forms of affected drug products.

 On Dec. 27, 2023, the FDA also revised the draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products, to articulate important changes, including added information about product sterility and preservative use, as well as a clarified scope regarding drug products that are not marketed under section 505G of the Federal Food, Drug and Cosmetic Act, or pursuant to an FDA approval or licensure. To read the revised guidance and for more information on how to submit comments to the docket, visit the guidance page. 

 

FDA Authorizes Florida’s Drug Importation Program

Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.  

Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety. 

Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported. Among other obligations related to this SIP, before drugs can be imported, Florida’s Agency for Health Care Administration must:

• Submit additional drug-specific information for the FDA's review and approval
• Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity  and compliance with the FDA-approved drugs’ specifications and standards
• Relabel the drugs to be consistent with the FDA-approved labeling

In addition, Florida’s Agency for Health Care Administration must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues. 

“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M. Califf, M.D. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

The FDA will exercise oversight to help ensure the authorized proposal is followed and that Florida’s program continues to meet the requirements in section 804 of the FD&C Act and the agency’s regulations. Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA. The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution.

States and Indian tribes may submit SIP proposals to the FDA for review and authorization under section 804 of the FD&C Act. Prior to authorization, a SIP proposal must provide all the information required by the FD&C Act and the FDA’s regulations. 

The FDA previously posted a small entity compliance question-and-answer guide and developed Tips for SIPs to assist sponsors in developing their proposals as a part of the agency’s ongoing commitment to working with interested states and tribes.

 

• Public Notifications:
  • ENDUREA contains hidden drug ingredients
  • ForeverMen contains hidden drug ingredient
  • Seraphim Z contains hidden drug ingredient

 

FDA Approves Many New Drugs in 2023 that Will Benefit Patients and Consumers

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives. 

In 2023, CDER approved 55 novel drugs, as detailed in our annual New Drug Therapy Approvals report. The active ingredient(s) in a novel drug have not been previously FDA-approved. We also took other important actions, such as expanding the indications or patient populations of some previously approved therapies. In addition, we approved new dosage forms or drug formulations and made some prescription drugs available over-the-counter.

Our 2023 actions target a wide range of disease areas. For example, we approved treatments for infectious diseases, including COVID-19, respiratory syncytial virus (RSV), and HIV. CDER also approved therapies for neurological conditions, such as amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and migraine. Moreover, we took approval actions for drugs targeting type 2 diabetes in children, different types of anemia, and chronic weight management, among other heart, blood, kidney, and endocrine disorders.

Read Mor

 

FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products

Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance for industry (GFI) #286 (VICH GL60) entitled, “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

 

CVM Federal Register Notices

The following Federal Register Notice is now available:

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability
January 25, 2024; 89 FR 4956

More CVM FR Notices

 FDA continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death.

Neptune's Fix products contain tianeptine, which is not FDA approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops and other locations.

Neptune Resources has agreed to voluntarily recall all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets. Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately.

Learn More

 

12/26/2023	12/20/2023	Hua Da Trading, Inc.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
12/26/2023	12/12/2023	Anish S. Shah, M.D./Siyan Clinical Research	Center for Drug Evaluation and Research | CDER	Clinical Investigator
12/26/2023	09/20/2023	Kyawkhin Inc.	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
12/26/2023	12/15/2023	Patcos Cosmetics Pvt. Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated
12/26/2023	12/12/2023	Omeza LLC	Office of Pharmaceutical Quality	CGMP/Finished Pharmaceuticals/Adulterated
12/26/2023	11/01/2023	Terragene S.A.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
12/26/2023	09/22/2023	Sonesta Medical AB	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
12/26/2023	11/30/2023	Distribuidora Jocorena Inc.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
12/21/2023	12/21/2023	My Vape Shack	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
12/20/2023	12/20/2023	Vaproma Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded