CDER Data Standards Program
CDER Data Standards Program
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Data Standards Program Strategic Plan and Board
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market. -
MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.
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Notice: Register of brokers authorised to deal in human medicines
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
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Decision: Human and veterinary medicines: register of licensed manufacturing sites
The MHRA register of licensed manufacturing sites: manufacturer specials – human (MS) and manufacturer specials authorisation – veterinary (MANSA) only.
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Biosimilars Research: Awards
Biosimilars Research: Awards -
FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting – 09/18/2025
The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities. -
Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) – 07/11/2025
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2028 through 2032. -
GDUFA Type II API DMF Payment Receipts Report
GDUFA Type II API DMF Payment Receipts Report -
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.
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Information by Drug Class
FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs. -
Abrysvo▼ (Pfizer RSV vaccine) and Arexvy▼ (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome following vaccination in older adults
There is a small increase in the risk of Guillain-Barré syndrome following vaccination with Abrysvo (Pfizer respiratory syncytial virus (RSV) vaccine) and Arexvy (GSK RSV vaccine) in adults aged 60 years and older. Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barré syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital.