Tag: FDA

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures […]

FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological […]

All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness:  Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout.  While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products […]

FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC.  The Guidance is a tool created in collaboration with the FTC, the […]

FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks.  The Guidance is the latest manifestation of a federal agency weighing in on the continually […]