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FDA Should Consider Free Speech Decisions: MIWG

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The Medical Information Working Group says FDA should incorporate principles from five recent Supreme Court free speech decisions ...

Oncology Panel Review AstraZeneca, Merck

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Federal Register notice: FDA announces a 12/17 Oncologic Drugs Advisory Committee meeting that with discuss an AstraZeneca supplem...

Rising Pharma Paying Over $3 Million in Price Fixing Charge

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The Justice Department says Rising Pharmaceuticals will pay over $3 million to resolve price fixing charges and will cooperate wit...

Tecentriq/Chemo Combo OKd for Lung Cancer

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FDA approves a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment ...

House Drug Price Bill Keeps New Drugs Away: White House

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The White House Council of Economic Advisors cautions that House Democrats drug price bill will keep innovative new drugs off the ...

Breakthrough for RightEye Parkinsons Test

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FDA grants RightEye a breakthrough device designation for the RightEye Vision System and its use in diagnosing Parkinsons Disease....

Aquestive Therapeutics Rolling NDA for Libervant

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Aquestive Therapeutics completes a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters.

Electronic Format Transparency Needed: Comment

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AdvaMed urges FDA to be transparent and flexible in developing plans for regulatory submissions in electronic format.

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company American Contract Systems.

House Hearing to Grill FDA on Foreign Inspections

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The House Energy and Commerce Oversight and Investigations Subcommittee plans a 12/10 hearing to question FDA on its foreign drug ...