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The FDA outlined plans coordinating CDER and the Office of Regulatory Affairs in inspecting manufacturing facilities seeking approval for new pharmaceuticals. Read More
Tasked with thinking beyond the agency’s current policy proposals, the FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner Scott Gottlieb. Read More
President Trump signed a package of legislation reauthorizing the FDA’s user fee agreements for the next five fiscal years — the culmination of over two years of work and negotiations between the federal government and private industry. Read More
Manufacturers must investigate and report to the FDA any deviation from regulations related to the core requirements of current good tissue practice within 45 days of discovery. Read More
A federal appeals court rejected a challenge by Otsuka Pharmaceuticals to the FDA’s decision to deny exclusive marketing rights to Otsuka’s antipsychotic injectable Abilify Maintena vis-a-vis a competing antipsychotic drug. Read More
FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
An FDA advisory committee voted 13-to-1 in favor of adding a warning about the risk of gadolinium retention to prescribing information for gadolinium-based contrast agents used in MRI scans. Read More