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 …
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Hyman Phelps McNamara
- DEA Administrative Decisions Update: DEA’s Questionable Practice of (Un)official NoticeOctober 25th, 2016
- In a Veloxis-Like Analysis, FDA Rules That EMBEDA 3-Year Exclusivity Does Not Block MORPHABOND 505(b)(2) ApprovalOctober 24th, 2016
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 …
- Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval?October 24th, 2016
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 …
- Promoting Your 510(k)-Pending Device: 5 Questions About FDA’s PolicyOctober 20th, 2016
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 …
- FSIS Issues Update to Guideline Regarding Animal-Raising ClaimsOctober 19th, 2016
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”) …
- As the Patient-Focused Drug Development “Pilot” under PDUFA V Concludes, Is FDA Passing the Baton to Patient Organizations?October 18th, 2016
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 …
- A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package InsertsOctober 17th, 2016
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 …
- Ut Oh … Not So Fast … DEA Withdraws Notice of Intent to Place Opioids Mitragynine and 7-Hydroxymitragynine – the Main Active Constituents of the Plant Kratom – in CSA’s Schedule IOctober 16th, 2016
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 …
- DOJ Weighs in on Discount Safe HarborOctober 13th, 2016
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 …
- FDA Finalizes Two Guidances Concerning Sunscreen TEAsOctober 12th, 2016
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 …
- FDAAA Asked & NIH Answered: The Final Rule on Clinical Trials Registration and Results ReportingOctober 11th, 2016
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 …
- Court Rejects Prosecution of Pharmacists Due to Lack of Fair Notice in FDC ActOctober 10th, 2016
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, …
- FDA Updates List of Drugs that May Not Be Compounded Under 503A and 503B: Preamble Reminds Industry when Listed Drugs Can Still Be CompoundedOctober 9th, 2016
By James E. Valentine & Karla L. Palmer – On October 6, 2016, the Food and Drug Administration (FDA or the Agency) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and …
- Update on the DeCoster Criminal CaseOctober 7th, 2016
By Jennifer M. Thomas – You might have read in our blog post two weeks ago that Quality Egg, LLC executives Austin (Jack) and Peter DeCoster had petitioned for panel rehearing and rehearing en banc of the Eight Circuit opinion affirming their three-month prison sentences. Last …
- Say Cheese! FDA Issues Warning Letter Based Solely on Company’s “Refusal”October 6th, 2016
By Anne K. Walsh & Robert A. Dormer – As we predicted it might, FDA effectively shut down a drug facility based solely on its conduct during an FDA inspection, without any observed GMP or safety concern related to the company’s products or procedures. In a …