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FDA requires J&J to include boxed warning on diabetes drugs

FDLI SmartBrief | May 17, 2017

The FDA has required Johnson & Johnson to include in the package inserts of its diabetes drugs Invokamet, Invokamet XR and Invokana a boxed warning regarding the risk of leg and foot amputations from taking the active ingredient canagliflozin. A safety analysis of a study conducted last year showed an increased risk of lower-limb amputation, mainly of the forefoot and toe, in patients with a high risk of cardiovascular events. Seeking Alpha (free registration) (05/16)


Late-stage trial shows cardiac problems with Amgen, UCB's osteoporosis drug

FDLI SmartBrief | May 22, 2017

Price calls for higher user fees, cuts in FDA's appropriations

FDLI SmartBrief | May 18, 2017

Congress, HHS consider proposals to make drugs more affordable

FDLI SmartBrief | May 16, 2017

Vertex's cystic fibrosis drug gets expanded indication

FDLI SmartBrief | May 18, 2017

Merck's Keytruda approved for 2 bladder cancer indications

FDLI SmartBrief | May 19, 2017

SMA drug from Cytokinetics wins FDA orphan status

FDLI SmartBrief | May 16, 2017

Nathan's, Curtis hot dogs recalled over metal contamination

FDLI SmartBrief | May 22, 2017

Bill aimed at simplifying device review process introduced in House

FDLI SmartBrief | May 19, 2017

Imara's sickle cell disease candidate gets rare pediatric disease designation

FDLI SmartBrief | May 16, 2017


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Call for proposals -- Advertising and Promotion Conference: For the Drug, Medical Device, and Veterinary Industries; May 25 deadline

FDLI SmartBrief | May 22, 2017

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

FDLI SmartBrief | May 22, 2017

Introduction to US Drug Law and Regulation, June 14-15, Boston

FDLI SmartBrief | May 19, 2017

Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Ed.

FDLI SmartBrief | May 19, 2017

Advertising and Promotion Conference: For the Drug, Medical Device and Veterinary Industries, Sept. 26-27, Washington, D.C.

FDLI SmartBrief | May 18, 2017




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