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Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
The FDA has issued a warning letter to Sanum-Kehlbeck for using the same equipment to produce penicillin and non-penicillin products and other quality violations. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than a related House bill. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
Stronger public-private partnerships, a streamlined clinical trials process, more funding for the FDA and beefed up safeguards on intellectual property are some of the ways to improve drug innovation, experts from government and industry said yesterday. Read More
Swiss drugmaker Novartis said it would give New York City-based Ophthotech Corp. up to $1 billion to license its experimental eye drug Fovista outside of the U.S. Read More
A Citizen Petition from law firm Hyman, Phelps & McNamara contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. Read More
Generic manufacturers are unlikely to be pleased with final draft guidance from the FDA on ANDA stability testing that continues to insist on six months of long-term stability data. Read More
Manufacturers of biosimilars need to demonstrate exactly how their products compare with the reference drugs as they design clinical trials, including by paying particular attention to assessments of exposure and effects of the product on the body, according to new FDA draft guidance on creating versions of the complex therapies. Read More
Specialty pharmaceutical firm Actavis has reached a deal to market generic versions of Valeant Pharmaceuticals’ acne-treating Acanya Gel, as well as its hypertension drug Tiazac, under a patent settlement agreement announced May 12. Read More