Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing Approaches to Obtain Data on Populations...more
On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more
The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more