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FY 2020 GDUFA Science and Research Highlights

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The CDER Offices of Generic Drugs and Pharmaceutical Quality issue a report on the FY 2020 GDUFA Science and Research Program acti...

How to Boost Quality System Inspection Success: Consultant

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Medical device consultant Adam Atherton offers three recommendations for preparing for an FDA quality system audit.

Review Period Determined on Lung Donor Device

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TransMedics OCS Lung System...

Review Period Determined on Ankle System

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for DT MedTechs Hintermann Seri...

Comments Reopened on Drug Naming Guidance

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Federal Register notice: FDA reopens the comment period on a 12/9/2020 notice entitled Best Practices in Developing Proprietary Na...

CGMP Violations at Chinas Foshan Biours Biosciences

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FDA warns Chinas Foshan Biours Biosciences about CGMP violations in its production of OTC drugs.

Dibar Nutricional CGMP Violations

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FDA warns Mexicos Dibar Nutricional about CGMP violations in its manufacturing of OTC drugs.

Medication Error Risks Due to Container Labels: Meeting

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Federal Register notice: FDA announces a 5/18-19 public meeting entitled Potential Medication Error Risks with Investigational Dru...

OND Met, Exceeded PDUFA Goals Amid Covid-19 Work: Report

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The CDER Office of New Drugs 2020 Annual Report describes lessons learned from Covid-19 and challenges OND will face in 2021 as th...

Alvogen Suing FDA Over Generic Belbuca Exclusivity

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Alvogen asks the DC federal court to order FDA to grant final approval to its ANDA for generic buprenorphine film and affirm that ...