FDA Clarifies Communication Rules For Medical Product Cos.
By Kellie Combs, Albert Cacozza, Gregory Levine, Douglas Hallward-Driemeier and Emerson Siegle (June 21, 2018, 4:06 PM EDT) -- On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling. In particular, the FDA issued final guidance documents laying out the agency's position with respect to (1) manufacturer communications with payors, formulary committees and similar entities, and (2) manufacturer communications consistent with FDA-required labeling. These guidance documents are the final versions of draft guidance documents issued on Jan. 18, 2017. The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information....
Stay ahead of the curve
In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
Create custom alerts for specific article and case topics and so much more!