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FDA Guidance on IDE Decisions to Allow Trials to Begin

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FDA releases a guidance on FDA Decisions for Investigational Device Exemption Clinical Investigations that is intended to facilita...

Alabama Court Reaffirms Brand Liability in Generic Drug Harm Suits

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The Alabama Supreme Court re-affirms that patients can sue brand drug makers for fraud or misrepresentation when plaintiffs are in...

Pfizer NDA for Palbociclib for Breast Cancer

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Pfizer submits an NDA for palbociclib for use in combination with letrozole for treating postmenopausal women with a certain advan...

FDA Rules for Labeling Use Code Carve Outs for ANDAs

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FDA deals brand drug makers a blow on use codes listed in the Orange Book and their use for market protection by allowing generics...

Turkish Man Pleads Guilty to Smuggling Misbranded Avastin

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Sabahaddin Akman, the Turkish owner of Ozay Pharmaceuticals, pleads guilty to charges of smuggling misbranded and adulterated canc...

Baxter Recalls 2 Dianeal Lots Over Particulate Concern

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Baxter International recalls two lots of Dianeal low calcium (2.5mEq/L) peritoneal dialysis solution with 2.5% dextrose 5,000mL du...

Avastin OK'd in Cervical Cancer Patients

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FDA approves Genentechs Avastin (bevacizumab) for use in treating patients with persistent, recurrent or late-stage (metastatic) c...

BIO Says Clarification Needed on Biosimilars Draft Guidance

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The Biotechnology Industry Organization says it has trouble understanding an agency draft guidance on Clinical Pharmacology Data t...

FDA Accepts Pfizer BLA for Meningococcal Vaccine

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FDA accepts for review a Pfizer BLA bivalent recombinant LP2086 (rLP2086), the companys vaccine candidate for preventing invasive ...

FDA Seeks Participants for Device Tools Pilot

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Federal Register Notice: FDA solicits proposals to participate in a pilot program for Medical Device Development Tools qualificati...