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August 13, 2024
The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.
August 09, 2024
The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.
August 08, 2024
The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.
August 05, 2024
Synovial sarcoma is a rare form of cancer impacting about 1000 adults in the United States each year, most of them men in their 30s or younger.
August 03, 2024
Potential conflicts of interest with advisory group members have led to EMA’s impartiality coming into questioned for some marketing authorization decisions.
July 29, 2024
The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.
July 26, 2024
An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.
July 25, 2024
The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.
July 24, 2024
Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.
July 23, 2024
While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.