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FDA Sentinel Collaboration on Covid Drugs

[ Price : $8.95]

The FDA Sentinel Operations Center at the Harvard Pilgrim Health Care Institute is working with TriNetX on projects to assess usag...

Biota Biosciences Recall 3 Drug Products

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Biota Biosciences recalls five lots of Cannabidiol Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables because they ...

Stericycle Predicts Surge in FDA Enforcement After Pandemic

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Stericycle says medical device and drug manufacturers should expect a significant uptake in FDA regulatory and enforcement action ...

Comments on Liquid Drug Flow Restrictor Guidance

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Four stakeholders give FDA recommendations for changes to a draft guidance on flow restrictors for oral liquid drug products.

Arthritis Advisory Panel Renewal

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Federal Register notice: FDA announces the renewal of the Arthritis Advisory Committee for an additional two years beyond the char...

FDA Posts 8 Info Collections Approved by OMB

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FDA publishes a list of eight information collections recently approved by OMB.

FDA Approves Lynparza for Prostate Cancer

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FDA approves AztraZeneca and Marcks Lynparza for treating patients with a specific form of prostate cancer.

FDA Approves Evoke Gimoti Brand Name

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FDA conditionally accepts Gimoti as the brand name for an Evoke Pharma diabetic gastroparesis nasal spray product.

Pandemic Adverse Event Reporting Guidance

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FDA issues a guidance on adverse event reporting priorities during the Covid-19 pandemic.

Source Plasma Donor Screening Guidance

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FDA issues a guidance recognizing donor history questionnaires prepared by the Plasma Protein Therapeutics Association.