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AbbVie filed a citizen petition Wednesday urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
The FDA is still not convinced that Sprout Pharmaceutical’s libido-enhancing drug for women is safe, particularly when mixed with alcohol, and has asked two of its advisory committees to consider whether alcohol should be contraindicated in the product’s labeling. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said Monday, adding that the current system of different expectations is not sustainable. Read More
A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for drugmakers to sue for patent infringement, a patent law attorney said. Read More