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European drugmakers will be allowed to make generics and biosimilars after the European Parliament voted in favor of manufacturing waivers that will allow their export. Read More
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Read More
A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More
The FDA will consider granting orphan status for different gene therapies—even ones in the same class as a previously designated orphan treatment—based on how the therapy is delivered, a high-ranking CBER official said Friday at the Food and Drug Law Institute’s annual meeting in Washington, D.C. Read More