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Guidelines on drugmaker-to-health system communication issued by BIO, PhRMA

FDLI SmartBrief | Jul 28, 2016

Guidelines aiming to improve communication between pharmaceutical companies and health care professionals about drug products were issued by the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America, with a call to the FDA to clarify the types of information the biopharmaceutical firms are allowed to share, along with approved labels. The guidelines contain nine principles that focus on providing appropriate context about data, accurately representing data and commitments to science-based communications. Morning Consult (07/27)


Hemophilia treatment from Pfizer, Spark gains FDA breakthrough status

FDLI SmartBrief | Jul 25, 2016

FDA exempts some drugs from import bans to ease shortages

FDLI SmartBrief | Jul 25, 2016

Janssen's multiple myeloma drug receives FDA breakthrough status

FDLI SmartBrief | Jul 27, 2016

Ebola vaccine from Merck to get priority reviews from FDA, EMA

FDLI SmartBrief | Jul 26, 2016

More E. coli cases prompt General Mills to expand flour recall

FDLI SmartBrief | Jul 26, 2016

Final guidance on adaptive design use released by FDA

FDLI SmartBrief | Jul 27, 2016

FDA approves revised label for fluoroquinolone antibiotics

FDLI SmartBrief | Jul 27, 2016

FDA reduces fees for 2017 generic-drug applications

FDLI SmartBrief | Jul 27, 2016

SPR Therapeutics' peripheral nerve stimulation system cleared by FDA

FDLI SmartBrief | Jul 29, 2016


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Introduction to Medical Device Law and Regulation Course, Nov. 2-3, Washington, D.C.

FDLI SmartBrief | Jul 29, 2016

Call for Session Topics: Enforcement, Litigation, and Compliance Conference, Deadline Today, July 29

FDLI SmartBrief | Jul 29, 2016

Tobacco Conference: Tobacco, Nicotine, and Alternative Products at a Regulatory and Legislative Crossroads, Oct. 27, Washington, DC

FDLI SmartBrief | Jul 28, 2016

Introduction to Food Law and Regulation Course, Sept. 22-23, San Francisco

FDLI SmartBrief | Jul 28, 2016

Introduction to Tobacco Law and Regulation Course, Oct. 26, Washington, D.C.

FDLI SmartBrief | Jul 27, 2016




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