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The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
Amgen is looking to head off future competition to a high cholesterol therapy, evolocumab, that hasn’t even been approved yet, with a patent infringement lawsuit against fellow biologics makers Sanofi and Regeneron. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
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