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The FDA finalized guidance for manufacturers looking to produce generic versions of opioid painkillers with abuse-deterrent labeling, as a part of the agency’s push to lower overall exposure to opioids and prevent new addictions. Read More
The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Read More
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers. Read More
The FDA is working to develop and finalize a handful of new guidances on bringing complex generics to market — including complicated medicines that may require alternate methods of establishing bioequivalence, as well as drug-device combination products that may be blocked by iterative patents. Read More
FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors. Read More
In the coming year, the FDA’s top priorities will include broadening non-prescription access to drugs and updating compounder regulations, according to Commissioner Scott Gottlieb. Read More
Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency. Read More