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Meeting on Drug eSubmissions and Data Standards

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Federal Register notice: FDA announces a 4/12 virtual public meeting entitled Prescription Drug User Fee Act of 2017; Electronic S...

FDA Adds 4 Bulk Drug Substances to Compounding List

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Federal Register notice: FDA evaluates certain substances that have been nominated for inclusion on a drug compounding list of bul...

FDA Inspection Efficiency Measure Drops

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FDA says the pandemic affected its ability to complete regulatory actions for inspected facilities within six months of the inspec...

Former FDA Digital Health Guru Joins Big Health

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Former FDA deputy commissioner for medical and scientific affairs Anand Shah joins Big Healths board of directors.

Hogan Lovells Hires Former FDA Investigator

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Law firm Hogan Lovells hires former FDA investigator Chris Middendorf as the firms regulatory affairs director.

Final Guidance on Good ANDA Submission

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Federal Register notice: FDA makes available a final guidance entitled Good ANDA Submission Practices.

FDA Cautions Lilly on Trulicity Social Media Post

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The CDER Office of Prescription Drug Promotion says a Lilly social media post for Trulicity is false and misleading because it ina...

Pass Hearing Aid Rule Quickly: Grassley, Warren

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Sens. Grassley and Warren urge FDA to quickly finalize its proposed rule on over-the-counter hearing aids.

Companies Need Interactive Web Site Archives: Article

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Hanzo compliance product manager Will Walker says companies need interactive Web archives to be able to show FDA how consumers vie...

FDA Responsibilities in New Preparedness Bill

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FDA would have many responsibilities under bipartisan legislation drafted to improve the nations pandemic and public health prepar...