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FDA Accepts AstraZeneca NDA for High Triglycerides

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FDA accepts for review an NDA from AstraZeneca subsidiary Omthera Pharmaceuticals for the investigational drug Epanova to treat se...

Guidance on Patient Counseling Section for Drug/Biologic Labels

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Federal Register Notice: FDA releases a draft guidance: Patient Counseling Information Section of Labeling for Human Prescription ...

Guidance on Electronic Source Data in Clinical Trials

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Federal Register Notice: FDA releases a guidance: Electronic Source Data in Clinical Investigations.

FDA Needs Good Reason to Detain Drugs: Comment

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Novo Nordisk and BIO ask FDA to spell out a drug detention policy that doesnt keep safe medicines from people who need them.

A New FDA Wrinkle? Just Dont Approve Nasty Products

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Washington commentator Bob Steeves says FDA may be deliberately refusing to approve any new tobacco products, thereby choking off ...

FDA Raises Many Ampligen Concerns

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FDA tells the Arthritis Advisory Committee it has concerns about the efficacy and safety of Hemispherx Biopharmas Ampligen in trea...

Merck, GE to Collaborate on Alzheimers Candidate

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Merck and GE Healthcare collaborate on a clinical study and license and supply agreement to use GEs investigational PET imaging ag...

Comments Sought on Device Review Assessment

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Federal Register Notice: FDA seeks comments on the comprehensive assessment of the device submission review process.

FDA Clears Ascendx Vertebral Fracture System

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FDA clears an Ascendx Spine 510(k) for its Ascendx VCF Repair System, intended for use in treating vertebral compression fractures...

Axelrad to be Woodcock Senior Advisor

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CDER Office of Regulatory Policy director Jane Axelrad is becoming Janet Woodcocks senior advisor to take the FDA lead on drug com...