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The FDA should make its consideration of ANDA first-filer status a far more public process, say generics firms that continue to seek more transparency and communications from the agency in general on the generic drug application process. Read More
The FDA has expanded market exclusivity from three to five years on all fixed-dose combination drugs that contain a new active ingredient, bowing to industry pressure for new incentives to develop the costly products. Read More
The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued yesterday. Read More
AbbVie has called off its plans to merge with Ireland-based Shire, citing the U.S. Treasury Department’s recent efforts to dissuade so-called tax inversions. Read More
Indian regulators are establishing a panel of experts to conduct a comprehensive review of existing forms and procedures, and recommend improvements to make the drug application process more user-friendly. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
Dr. Reddy’s Laboratories has settled a class-action lawsuit over its alleged role in delaying generic entry of AstraZeneca’s heartburn drug Nexium in return for assisting plaintiffs in their case against AZ and the remaining generics manufacturer defendants. Read More