By Ricardo Carvajal – FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled. A disclosure requirement is included in four of the FSMA rules, namely the preventive controls rule for …
By James E. Valentine & Karla L. Palmer – We reported earlier this month that the Food and Drug Administration (FDA) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and 503B …
By John A. Gilbert, Jr. & Andrew J. Hull – The Controlled Substances Act (“CSA”) and regulations promulgated by the Drug Enforcement Administration (“DEA”) provide for a right to an administrative hearing in matters where DEA seeks denial or revocation of a DEA registration to handle …
By Karla L. Palmer & Andrew J. Hull – From time to time, we have posted on significant final orders in DEA administrative cases. We now plan to blog on these cases in a more regular fashion, partly because we have noted that a number of these …
By Kurt R. Karst – There are few things this blogger likes more (workwise at least) than having a hot cup of joe in the morning while reading through an FDA exclusivity decision. (Reading through the latest edition or supplement to the Orange Book while enjoying …
By Robert W. Pollock* & Kurt R. Karst – If there’s something strange in your neighborhood; Who you gonna call? If there’s something weird, and it don't look good; Who you gonna call? Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange …
For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending. Yet, questions about how to apply this policy still remain. In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions …
By Riëtte van Laack – A couple of weeks ago, the Food Safety Inspection Service of the USDA (FSIS) announced the availability of an updated compliance guideline regarding animal-raising claims. The previous guideline dated from 2002. Traditionally, the FSIS has interpreted the Federal Meat Inspection Act (“FMIA”) …
By James E. Valentine – In what can only be described as a success story, FDA’s Patient-Focused Drug Development (“PFDD”) initiative has opened the doors to hundreds of patients, caregivers, and other patient representatives to share their experiences with their diseases and conditions with FDA. This …
By Jeffrey K. Shapiro – In 1976, FDA first began comprehensive regulation of medical devices. Among the new statutory provisions, there was one requiring persons registering with FDA to list all marketed devices. Each device on the list was to be accompanied by a copy of …
By Karla L. Palmer – In a move unprecedented in recent memory, on October 13, 2016, DEA published a Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7- Hydroxymitragynine (i.e., kratom) in schedule I of the Controlled Substances Act. As background, a little over a …
By Serra J. Schlanger & Alan M. Kirschenbaum – We previously reported (here and here) on two opinions handed down by Judge Rya Zobel of the Federal District Court for the District of Massachusetts construing the discount safe harbor under the Federal health care program antikickback …
By Riëtte van Laack – The Sunscreen Innovation Act (SIA) was enacted in 2014. It amended the FDC Act to provide specific deadlines for FDA’s review of time and extent applications (TEAs ) for sunscreen active ingredients. Thus far, FDA has proposed sunscreen orders for all …
By James E. Valentine & David C. Clissold – Nearly two years after releasing its Notice of Proposed Rulemaking (“NPRM”), and with about 900 comments from the public to consider, the National Institutes of Health (“NIH”) has published its Final Rule on clinical trials registration and …
By Andrew J. Hull – There has been an interesting development in the ongoing prosecution of a slew of former officers and employees of the New England Compounding Center (NECC). As you may recall, the NECC was responsible for shipping allegedly contaminated compounded steroid epidural products nationwide, …
