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FDA Opens Drug Supply Chain Security Act Portal

[ Price : $8.95]

FDA launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.

FDA Denies Apixaban ANDA Petition for Safety

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FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs El...

SCA Pharma Issued 10-Item FDA-483

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FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.

Regenerative Medicine Consensus Standards Guide

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FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.

Similar Intas CGMP Violations

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FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India...

Korsuva Regulatory Review Period

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (...

Cosela Regulatory Review Period

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (tr...

Info Collection on Device Shortages Data

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Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.

Serious Reaction to Some Anti-Seizure Meds: FDA

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FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure dru...

Acelyrin Auditing Izokibep Trial Issues

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Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.