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Generic Drug RTR Letters Likely to Increase: Consultant

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Lachman Consultants Bob Pollock says the Office of Generic Drugs is likely to refuse to accept more ANDAs under requirements in a ...

Scheduled Advisory Committees Still On During Government Shutdown

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FDA honors scheduled advisory committee meetings during the current government shutdown.

Electronic Application Form Oversight MAPP Out

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CDER issues an electronic application form oversight MAPP.

Wyeth Menopause Drug Approved by FDA

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FDA approves a Wyeth Pharmaceuticals NDA for Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-seve...

Hypercholesterolemia Study Positive for Alnylam Drug

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Alnylam Pharmaceuticals reports positive Phase 1 study results of its ALN-PCS RNAi drug targeting PCSK9 for treating hypercholeste...

FDA Clears Nucletron Brachytherapy System for Skin Cancer

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FDA clears a Nucletron 510(k) for Esteya, an electronic brachytherapy system for treating skin cancer.

Hospira Recalls Drugs Due to Glass Strands

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In its fifth GMP-related recall since May 1, Hospira recalls one lot of metoclopramide injection and two lots of ondansetron injec...

Forest Sues Generic Company Over Savella ANDA

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Forest Laboratories and Royalty Pharma Collection Trust jointly file a lawsuit in Delaware federal court against First Time U.S. G...

FDA Accepts Anacor NDA for Nail Fungus Topical Drug

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FDA accepts for review an Anacor Pharmaceuticals NDA for tavaborole, an investigational drug for topically treating onychomycosis ...

Nurelin Meets Trial Endpoint

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Adamas Pharmaceuticals says its Nurelin met its primary endpoint in a Phase 2/3 trial in treating levodopa-induced Dyskinesia in P...