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Focus on Regulation

Tag Archives: promotion

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of

New Charter in France for Pharmaceutical Promotion

The CEPS (French Health Products Economic Committee) and LEEM (French Pharmaceutical Industry Association) signed on 15 October 2014 a new Charter on information provided for promotional purposes via solicitation or prospection. This charter had been in discussions since 2013. It replaces and broadens the scope of the previous charter applicable to medical representatives’ activities. The

OPDP Issues Another Enforcement Letter Aimed at Preapproval Promotion

The Food and Administration’s (FDA’s) Office of Prescription Drug Promotion (“OPDP”) issued an enforcement letter to CBA Research, Inc., on April 25, 2013 regarding improper promotion of its investigational new drug CBT-1® (tetrandrine) Capsule (“CBT-1”).  According to OPDP, the company’s website misleadingly promoted the investigational new drug as safe and effective and  overstated its efficacy.