By Mark I. Schwartz* – On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from …
By Jay W. Cormier – It is no surprise that in a presidential election year that every piece of legislation in Washington gets an extra dose of political theater. Federal funding for Zika virus research is no exception. The President and the NIH have been asking …
By Jay W. Cormier – As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here). Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see …
This spring marked the 40th Anniversary of the Medical Device Amendments. Thanks to significant technological advancements there is no sign of slowing down for medical device regulatory developments. Devices were a prominent focus at this year’s Food and Drug Law Institute’s Annual Conference. Sessions included …
By Karla L. Palmer – FDA announced last week the availability of a draft guidance document titled, “Insanitary Conditions at Compounding Facilities.” This draft is FDA’s first attempt to assist compounding facilities and state regulators in identifying “insanitary conditions so they can implement appropriate corrective actions.” …
A breakthrough paper by Hyman, Phelps & McNamara, P.C’s Frank Sasinowski and Alexander Varond concerning FDA’s Subpart H approvals has just published in the Food and Drug Law Journal. Titled “FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence,” the paper examines the …
By Jennifer D. Newberger – On July 29, 2016, FDA finalized its guidance document, General Wellness: Policy for Low Risk Devices. The draft guidance, on which we posted here, was issued in January 2015. The final guidance is nearly identical to the draft, while providing a …
By Riëtte van Laack – Yesterday, FDA announced the availability of a webpage providing information to industry regarding the requirements of the recently finalized Nutrition Facts and serving size regulations. FDA clarifies that until the compliance date of July 26, 2018 (or July 26, 2019 for companies …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Serra J. Schlanger has joined the firm as an Associate. Ms. Schlanger assists clients with FDA regulatory strategy, compliance matters, and enforcement issues. She has specific expertise with regard to federal and state health …
The American Conference Institute (“ACI”) will hold the Second Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food on September 13-15, 2016, in New York City at The Carlton Hotel. This forum will help attendees make sense of the legal …
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 28th iteration, is slated to take place at the Omni Parker House in Boston, Massachusetts from September 22-23, 2016. The conference is billed as the premier event to provide folks with a roadmap …
By Kurt R. Karst – Like the Running of the Bulls in Pamplona, Spain each Summer, we wait with bated breath each July and August to see how FDA-regulated companies might get gored when FDA releases the user fee rates for the next fiscal year. Over …
By Kurt R. Karst – Late last week, Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia issued a 57-page Memorandum Opinion handing FDA a victory on the scope of 3-year new clinical investigation exclusivity. The decision came in a case …
By Jennifer D. Newberger – With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content …
By Dara K. Levy – The Automated Commercial Environment (ACE), which went into effect for FDA-regulated products on June 15, 2016 (after several delays), is an electronic system operated by Customs and intended to automate import processing and expedite reviews for electronic import filings. It replaces …
