On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
A new drug’s effectiveness must be established by “substantial evidence,” which is defined in 505(d) of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA has interpreted the law as generally requiring at least two...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more
FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more