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Pfizer Wants Purdue OxyContin Petition Denied

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Pfizer calls on FDA to deny a recent Purdue Pharma petition asking that Pfizer be required to reference a Purdue drug in its appli...

Omthera Cites Amarin Case for Epanova Exclusivity

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Omthera says a federal court decision in the Amarin case supports its argument that its Epanova is entitled to five-year new chemi...

FDA Clears Reflexion Health Vera Physical Therapy Tool

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FDA clears a Reflexion Health 510(k) for its motion-tracking physical therapy tool, Vera.

Production/Process Controls Top QS Citation in Device Inspections

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CDRH says Production and Process Controls and Corrective and Preventive Actions continue to be the most frequently cited Quality S...

Lawyers Suggest Future FDA Enforcement Trends

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Attorneys Raymond Bonner and William McConagha predict a busy FDA enforcement schedule in the next three to five years, especially...

Patient, Physician Groups Endorse Califf as Next FDA Head

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In the face of stiffening opposition from Public Citizen, among others, a letter addressed to Senate leaders by 50 patient and hea...

Generics Saved U.S. $254 Billion Last Year

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A new report finds that the U.S. health care system saved a record $254 billion in 2014 from generic drugs.

Shorter Drug R&D Times Yield Market Exclusivity

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A Tufts Center for the Study of Drug Development analysis shows that marketing exclusivity often goes to the company that can shor...

CDER Posts Policy on NDA Classification Codes

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A new CDER policy document describes the NDA classification code the Center assigns to a submission based on product characteristi...

Guidance on Developing HIV-1 Drugs

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Federal Register Notice: FDA releases a guidance: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Tr...