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Public Meeting on Grandfathered Dietary Supplements

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Federal Register notice: FDA announces a 10/3 public meeting entitled Development of a List of Pre-DSHEA Dietary Ingredients.

Ritalin NDA Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsul...

Gynorest Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 ...

AbbVie Files NDA for Endometriosis Pain

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AbbVie files an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for...

FDA Praised for Supply Chain Enforcement Delay

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Stakeholders praise FDA for enforcement discretion for manufacturers to meet Drug Supply Chain Security Act product identifier req...

QLRAD Marketing Unapproved Medical Device: FDA

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FDA warns a Netherlands firm it is marketing a medical device in the U.S. without agency approval or clearance.

FDA Clinical Hold on Cell Therapy After Patient Dies

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FDA places a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia and in blast...

Significant Violations at Steiner Clinical Study Site

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FDA warns Steiner Biotechnology about violations in its role as a sponsor-investigator of medical device clinical trials.

Medical Device Study Site Violations

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FDA warns Entellus Medical about violations in its work as sponsor of a medical device clinical study.

Ban UHDU Opioid Analgesics: Groups

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Six health groups ask FDA to remove ultra-high dosage unit opioid analgesics from the market because their harms outweigh the bene...