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FDA issues 14 warning letters, 4 online advisories over unapproved cancer drugs

FDLI SmartBrief | Apr 26, 2017

Four online advisory letters and 14 warning letters were issued by the FDA to US-based firms for marketing and selling more than 65 products with claims that they could cure, prevent or reverse cancer, although the claims are not proven and the products have not gotten the approval of the FDA. The agency gave the companies 15 days to respond with plans on how they will address their violations, and companies that do not comply face product seizure and criminal prosecution that could result in a year in federal prison and a fine of either $100,000 or twice the company's gain on the fraudulent products. Regulatory Focus (04/25) Pharmacy Times online (04/25)


Hash browns recalled due to possible golf ball contamination

FDLI SmartBrief | Apr 24, 2017

Bills would roll back regulations on e-cigarettes, vaping devices

FDLI SmartBrief | Apr 26, 2017

Samsung wins FDA approval for Remicade biosimilar

FDLI SmartBrief | Apr 24, 2017

Mylan sued W.Va. to keep EpiPen on preferred Medicaid drug list

FDLI SmartBrief | Apr 25, 2017

FDA warns against codeine, tramadol for youths, breast-feeding mothers

FDLI SmartBrief | Apr 21, 2017

MHRA releases 2017-2018 post-Brexit business plan

FDLI SmartBrief | Apr 24, 2017

Biosimilar patent case to proceed in US Supreme Court

FDLI SmartBrief | Apr 21, 2017

Teva introduces asthma inhaler, generic version

FDLI SmartBrief | Apr 24, 2017

Real-world data support early treatment with MS drugs, Biogen reports

FDLI SmartBrief | Apr 27, 2017


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Tobacco products agenda highlights at the Annual Conference, May 4-5, Washington, D.C.

FDLI SmartBrief | Apr 28, 2017

Webinar: REMS: Key Issues and Best Practices, May 23, 2-3:30 p.m. ET

FDLI SmartBrief | Apr 28, 2017

One week away: 2017 Annual Conference, May 4-5, Washington, D.C.

FDLI SmartBrief | Apr 27, 2017

New release available for pre-order! How to Comply with Drug CGMPs, 2nd edition

FDLI SmartBrief | Apr 27, 2017

Drug, medical device and biologics agenda highlights at the Annual Conference,
May 4-5, Washington, D.C.

FDLI SmartBrief | Apr 26, 2017




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