On July 9, 2024, the Food and Drug Administrations (FDA) replaced a 10-year-old draft industry guidance on misinformation and social media information on prescription drugs and medical devices. The new guidance assists...more
The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more
Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
Dr. Mark Fleckner, a board-certified New York ophthalmologist, will pay almost $7 million to settle civil fraud claims arising from giving patients imported macular degeneration drugs that had not been evaluated or approved...more
On January 11, 2018, the Food and Drug Administration (FDA) released its 2018 Strategic Policy Roadmap, which sheds light on the agency’s key focus areas for the year. This Roadmap builds on some of the FDA’s existing work,...more