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Commentary: FDA's proposed guidance on off-label communications may spur discussion

FDLI SmartBrief | Apr 30, 2015

The FDA's recent proposed guidance on off-label communications may finally prompt a serious discussion of the differences between off-label communications and off-label marketing, writes Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest. "The new FDA draft guidance opens the door for companies to share truthful, scientifically accurate and data-driven information with health care professionals to inform treatment decisions," he contends. Medical Marketing & Media (04/29)


FDA approves generic versions of Otsuka's antipsychotic drug

FDLI SmartBrief | Apr 29, 2015

Quality issues prompt Wockhardt to recall some meds in U.S.

FDLI SmartBrief | Apr 28, 2015

Takeda to settle Actos cancer-risk lawsuits for about $2.4B

FDLI SmartBrief | Apr 30, 2015

Review quantifies death, cancer risks of cigar smoking

FDLI SmartBrief | Apr 28, 2015

Boston Scientific to pay nearly $119M to resolve transvaginal mesh cases

FDLI SmartBrief | Apr 30, 2015

Biologics license application for Bristol-Myers' Opdivo accepted by FDA

FDLI SmartBrief | May 01, 2015

Amgen's melanoma immunotherapy wins backing from advisory panel to FDA

FDLI SmartBrief | Apr 30, 2015

Lawmakers move on 21st Century Cures bill

FDLI SmartBrief | Apr 30, 2015

HHS regulation lowers fluoride levels in drinking water

FDLI SmartBrief | Apr 28, 2015


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FDLI SmartBrief | May 01, 2015

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FDLI SmartBrief | Apr 30, 2015

Registration just opened for the 2015 Advertising & Promotion Conference!

FDLI SmartBrief | Apr 30, 2015

Food and Drug Law and Regulation, 3rd edition, is here!

FDLI SmartBrief | Apr 29, 2015




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