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CDER Policy on ANDA Amendment Filing Reviews

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CDER posts a policy document on the Review of ANDA Amendments and Supplements by the Division of Filing Review.

Ex-FDA Chief of Staff Joins DC Law Firm

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Former FDA chief of staff and deputy chief counsel Denise Esposito joins Covington & Burling as a partner and co-chair of its food...

China API Inspection Passes with No 483 Citations

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FDA inspects a ScinoPharm drug manufacturing facility located in the Changshu Economic Development Zone in Jiangsu Province, China...

Make Generics Look Like Brand Name Drugs: OGD

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CDER urges generic drug makers to make their generic copies look as much like the brand drug to help with patient compliance.

FDA Rare Pediatric Disease Status for ArmaGen Drug

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FDA grants ArmaGen a rare pediatric disease designation for AGT-181, a potential treatment for patients with Hurler syndrome.

Amgen NDA for Etelcalcetide Accepted for Review

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FDA accepts for review an Amgen NDA for etelcalcetide (formerly AMG 416) for treating secondary hyperparathyroidism in patients wi...

FDA Panel Recommends Stricter Labeling for Fluoroquinolones

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FDAs Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommend a revised indicat...

Dr. Reddys Hit With Warning Letter Over India Facilities

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Dr. Reddys Laboratories joins the growing list of India-based companies coming under intense scrutiny by FDA after receiving a War...

CDRH Accredits 3 UDI Issuing Agencies

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CDRH accredits three organizations as Unique Device Identifier (UDI) issuing agencies GS1, Health Industry Business Communication...

FDA Safety Review Positive for BMS Plavix

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An FDA safety review determines that long-term use of Bristol-Myers Squibbs blood-thinning drug Plavix (clopidogrel) does not incr...