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Former CDER Product Quality Director Joins Parexel

[ Price : $8.95]

Former CDER Office of Process & Facilities director Robert Iser joins Parexel as vice president of regulatory consulting services.

Draft Guide on Biosimilar User Fees

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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Biosimilar User Fee Amendment...

Voluntis 510(k) for Insulia Cleared by FDA

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FDA clears a Voluntis 510(k) for Insulia, a digital companion for people with Type 2 diabetes that the company says can integrate ...

Pull Benicar from Market: Public Citizen

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Public Citizen says FDA should order Daiichi Sankyos Benicar and related olmesartan medoxomil drugs off the market due to a risk o...

Progress and Some Concerns in NARMS Report

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FDA releases the 2015 National Antimicrobial Resistance Monitoring System (NARMS) report showing some gains in reducing antibiotic...

FTC Finalizes Abbott/Alere Acquisition Consent Order

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The Federal Trade Commission finalizes a consent order to resolve its concerns about the effect on medical device competition for ...

Baxter Recalls 1 Lot of Nexterone

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Baxter International recalls one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection due to the potential presence ...

Acorda Phase 3 Parkinsons Study Sees 5 Deaths

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Acorda Therapeutics says a Phase 3 study of tozadenant for Parkinsons disease is linked to five deaths.

Takeda Gout Drug has Higher Cardiovascular Risks: FDA

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An FDA drug safety alert says that Takedas gout drug Uloric (febuxostat) may have an increased risk of heart-related death when co...

Draft Guidance on Biosimilar User Fees

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FDA posts a draft guidance on Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.