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2 Observations in OSO Biopharmaceuticals FDA-483

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FDA releases the FDA-483 with two observations issued following an inspection at OSO Biopharmaceuticals Manufacturing.

BMS Closing Opdivo Brain Tumor Program

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Bristol-Myers Squibb decides to end its Opdivo development program for treating some brain cancer patients.

Operation Warp Speed Invests in Merck Covid Drug

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Operation Warp Speed is spending $356 million for doses of a Merck drug to treat severe Covid-19 patients.

FDA 2020 Covid Drug and Biologic Activities Analyzed

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Attorney Joanne Hawana reviews FDA Covid-related drug and biologic actions in 2020, praising the agency for its transparency in is...

FDA Approves Amphastar Generic Glucagon

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FDA approves Amphastars generic glucagon for injection to treat severe hypoglycemia in diabetics.

FDA Authorizes Interscope EndoRotor System

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FDA authorizes Interscopes EndoRotor system for resecting and removing necrotic tissue for patients with walled-off pancreatic nec...

5 Companies Warned for Illegal Marketing of Unapproved CBD Products

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FDA warns five companies they are illegally marketing CBD-containing products that the agency considers to be unapproved new drugs...

Laparoscopic Power Morcellator Labeling Guidance

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FDA issues a guidance and other documents intended to increase the safety of laparoscopic power morcellators used in gynecologic s...

Multiple Violations in Herbacil Antiseptic Hand Sanitizer

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FDA warns Mexicos Broncolin about multiple violations in its production and marketing of Harbacil antiseptic hand sanitizer.

Sunstar Americas Expands Paroex Recall

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FDA says Sunstar Americas has expanded the expiration dates in its Paroex recall that is due to microbial contamination.