In June 2016 CDRH released the draft guidance “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, Enforcement Decisions” (see our earlier post here). In the waning days of 2016, CDRH finalized the guidance. The final guidance is largely unchanged from the draft with …
Week 52 is often more laid back than any of the other 51 weeks in the calendar year. It offers us a chance to sift through and clean out the office in preparation for yet another busy year. But it’s also a chance for this …
It’s been a couple of months since the dust has settled from FDA’s October 26, 2016 approval of Mylan Pharmaceuticals Inc.’s (“Mylan’s”) ANDA 078276 for a generic version of Daiichi Sankyo Inc.’s (Daiichi’s) BENICAR (medoxomil) Tablets, 5 mg, 20 mg, and 40 mg, so we …
Approximately one year ago, on New Years Eve, FDA surprised the device industry with a draft guidance on emerging postmarket device signals (see our post on the draft guidance here). On December 14, FDA issued the final guidance document: Public Notification of Emerging Postmarket Device …
Change is inevitable (cue David Bowie’s “Changes”). Sometimes change occurs slowly and goes (largely) unnoticed, and sometimes it comes fast and unexpected. Sometimes change is good, and sometimes it’s not. Change should not be confused with progress, growth or retreat, which are not inevitable, but …
The 21st Century Cures Act was signed into law on December 13, 2016. The Act addresses acceleration of medical product discovery, development, and delivery. Hyman, Phelps & McNamara, P.C. ("HP&M") will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, …
The meaning of product dating on foods and why companies use it (are they required to do so?) is a frequent question. With the exception of infant formula, which by regulation must include product dating, there are no federal regulations requiring product dating. (States may …
We’ve previously posted some summaries of the 21st Century Cures Act (Cures Act), which the President signed into law on December 13, 2016 (Public Law No. 114-255). (Those summaries are available here, here, and here.) This post focuses on only one section of the new …
On December 9, 2016, FDA released a guidance document addressing its Drug Supply Chain Security Act (DSCSA) implementation: “Identification of Suspect Product and Notification.” The Federal Register Notice announcing the release of this (partially, as explained below) final guidance explains that it is the result …
Your friendly neighborhood bloggers were tempted to headline this post with a Buzzfeed worthy headline such as “When FDA pointed out THIS ONE THING, industry was SHOCKED!” or “FDA issues flood of letters – 25% of 2016 output in a single day. What happened next …
As we previously reported, the President signed into the law the 21st Century Cures Act (Act) on December 13, 2016 (find the full text here). This post is part two of a two-part post that summarizes the relevant provisions related to development of drugs and …
On December 7, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Final Rule amending the safe harbor regulations under the Federal health care program antikickback statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) and established exceptions to the Civil Monetary …
The 21st Century Cures Act (Act) was passed by the House on November 30, 2016 and the Senate on December 7, 2016. The President signed it into law on December 13, 2016. The Act contains three primary titles that address acceleration of medical product discovery, …
As we previously reported, in April 2016, the FTC announced several settlements regarding all natural claims for cosmetic products. In addition, the FTC filed an administrative complaint against California Naturel, Inc., (the Company) for falsely advertising its sunscreen product as “all natural” in violation of …
This week, FDA announced (here and here) that it is making available adverse event information for foods (including dietary supplements, food additives, and color additives) and cosmetics the Agency has received through its Center for Food Safety and Nutrition (CFSAN) Adverse Event Reporting System (CAERS). CAERS …
