By Ricardo Carvajal – In an unusual “Early Alert,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) publicly took FDA to task for allegedly lacking “an efficient and effective food recall initiation process that helps ensure the safety of …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas of food and drug law and regulation to assist with a growing practice. Strong verbal …
By Allyson B. Mullen – It is an open secret that at some point in every device company’s life one or more of its devices will likely be out of compliance with the Federal Food, Drug, and Cosmetic Act. That is because the regulatory scheme is …
By Kurt R. Karst – It’s been a little more than 4.5 years since we first revealed in a December 11, 2011 FDA Law Blog post the fruits of our hunt for the mythical list of pending proceedings under the Drug Efficacy Study Implementation …
By Karla L. Palmer – FDA published last week two final “Interim Policies” for compounding using bulk substances under Sections 503A and 503B of the Federal Food, Drug and Cosmetic Act (here and here). FDA first published draft policies back in October 2015 (see our previous …
By Kurt R. Karst – Earlier this week, Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) announced the introduction of bipartisan legislation that they say is intended to “end inappropriate delay tactics that are used by some brand-name drug manufacturers …
By Allyson B. Mullen – Symbols have been an accepted part of device labeling outside of the U.S. for many years. In the U.S., however, symbols alone have not been permitted on medical device labeling, with the exception of guidance allowing use of “Rx Only.” To …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …
By Allyson B. Mullen – On June 10, FDA issued the draft guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers.” At a mere six pages long, this guidance is not tipping the scales by any means, but its few short pages contain some important …
By Riëtte van Laack – On May 31, 2016, the Food Safety Coalition submitted a Petition to the Food Safety Inspection Service (FSIS) to amend regulations requiring safe food handling instructions (SHI) on certain meat and poultry products. The Federal Meat Inspection Act (FMIA) and the Poultry …
By Riëtte van Laack As we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA. Plaintiff markets a medical food for women with lupus, Prastera® DHEA. Medical foods may be marketed without pre-market approval by …
by Jennifer Newberger - Since September 1995, FDA and CMS have operated under an interagency agreement (IA) regarding Medicare coverage for investigational devices. That same month, CMS also published a rule that permitted Medicare coverage of certain devices with an approved investigational device exemption (IDE) in place. …
By Kurt R. Karst – It was just last week when one orphan drug exclusivity labeling carve-out case (presumptively) came to an end when the U.S. Court of Appeals for the District of Columbia Circuit ruled for FDA in the context of a generic version of …
By Jenifer R. Stach & Ricardo Carvajal – Carrying through on what had been designated as a high priority item, FDA rolled out its sodium reduction initiative with several actions, all on the same day. On June 1, 2016, FDA published a Federal Register notice to announce …
By Kurt R. Karst & Douglas B. Farquhar – On June 3, 2016, a three-judge panel (Judges Thomas B. Griffith, Brett M. Kavanaugh, and Robert L. Wilkins) of the U.S. Court of Appeals for the District of Columbia Circuit ruled for FDA and Intervenor-Appellee Sandoz, Inc. …
