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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Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency.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
“New drugs and vaccines are being brought to the market for the first time in public health programs in settings where the safety monitoring and regulatory systems need strengthening,” said MHRA’s CEO Ian Hudson. Read More
In a clinical trial, patients treated with lenvatinib along with everolimus lived approximately 10 months longer than those who took everolimus alone. Read More