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Report: Billions of dollars wasted due to abuse of REMS

FDLI SmartBrief | Jul 24, 2014

A Generic Pharmaceutical Association report released Wednesday found that brand-name drugmakers are manipulating the FDA's risk evaluation and mitigation strategies to repel generic competitors. Matrix Global Advisors reported that such manipulation has delayed the arrival of 40 potential generic drugs, which costs consumers about $5.4 billion yearly. "This study raises serious concerns about whether safety protocols are being inappropriately used to inhibit access to cheaper alternatives," said Sen. Richard Blumenthal, D-Conn. Reuters (07/24)


Filing of first biosimilar offers glimpse of possible savings for U.S.

FDLI SmartBrief | Jul 25, 2014

Medical, pharma groups urge CMS to explain Sunshine Act disclosures

FDLI SmartBrief | Jul 29, 2014

Final rule prohibits "split predicates" under 510(k) process

FDLI SmartBrief | Jul 30, 2014

Medtronic agrees to pay $2.8M to settle insulin pump lawsuit

FDLI SmartBrief | Jul 28, 2014

Flonase from GSK approved for sale OTC

FDLI SmartBrief | Jul 25, 2014

Ruling on farm antibiotics raises public concerns

FDLI SmartBrief | Jul 25, 2014

FDA faces greater-than-expected rush of generic applications, expert says

FDLI SmartBrief | Jul 30, 2014

Purdue Pharma's extended-release painkiller wins FDA nod

FDLI SmartBrief | Jul 24, 2014

Moves to reimburse off-label drugs in EU opposed by pharma

FDLI SmartBrief | Jul 28, 2014


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Pharmaceutical Drug Law & Regulation — An FDLI Webinar in partnership with USP, Sept. 10 and on-demand

FDLI SmartBrief | Jul 31, 2014

Don't miss out on this historic event: 30th Anniversary of the Hatch-Waxman Amendments, Sept. 18

FDLI SmartBrief | Jul 31, 2014

Advertising & Promotion Conference — September 29-30, 2014

FDLI SmartBrief | Jul 30, 2014

Save the date: Enforcement, Litigation, and Compliance Conference PLUS holiday reception, Dec. 8-9

FDLI SmartBrief | Jul 30, 2014

FDA emerging issues: An FDLI Symposium with Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Oct. 20

FDLI SmartBrief | Jul 29, 2014




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