Last week, just before the new Orange Book (print and electronic versions) made its debut, we opined (see our previous post here) that changes to the Orange Book Preface would likely be made. Now that the print version of the Orange Book is available (here), …
In a Complaint filed on January 27, 2017 in the U.S. District Court for the District of Columbia, ANDA applicant Amneal Pharmaceuticals LLC (“Amneal”) alleges that FDA incorrectly ruled that Amneal forfeited eligibility for 180-day exclusivity for generic versions of NAMENDA XR (memantine HCl) Extended-release …
FDA recently put forth its first interpretation of the Regenerative Advanced Therapy (“RAT”) designation program, which was established by section 3033 of the 21st Century Cures Act. Although it consists of just a few short paragraphs on FDA’s website (here), the guidance confirms that FDA …
In late November, FDA announced that it would not be finalizing the 2014 draft LDT Guidance. The Agency had, however, done a significant amount of work regarding the draft guidance and evaluating the regulatory framework for lab tests. In an effort to document the work …
FDA’s October 6, 2016 Final Rule implementing certain provisions of the December 8, 2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, ushered in a lot of changes for NDA and ANDA applicants and sponsors (see our previous post here). The new …
Hardly a day goes by that we don’t see a press release or announcement that a company has requested or received from FDA’s Office of Orphan Products Development (“OOPD”) designation of its drug or biological product as an “orphan drug.” There’s a reason for that: …
On Wednesday, January 25, 2017, a new chapter will begin in the decades-old story of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). According to a note posted on the Electronic Orange Book website last week (as well as in a separate …
The Hemp Industries Association has filed a Petition for Review in the Ninth Circuit to block implementation of the Drug Enforcement Administration’s (“DEA’s”) recent final rule on Marijuana extracts. The DEA final rule designates non-psychoactive cannabinoids, including cannabidiol, as “marihuana extract” and adds all cannabinoids, …
On January 20, 2017, the Trump administration took a first step toward delaying, reconsidering, and potentially undoing numerous regulations and policies issued by the Obama administration. In order to ensure that “the President’s appointees or designees have the opportunity to review any new or pending …
It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address …
Loyal readers know that we at the FDALawBlog have been closely following a significant Park Doctrine case wending its way through the courts, involving father and son Austin (“Jack”) and Peter DeCoster, former executives of Quality Egg, LLC. In an earlier blog posting, we stated …
After a relatively slow first 11 months of 2016, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a flurry of letters in the span of 9 days in December, more than doubling the enforcement letters issued up to that point in the year. And the …
On December 29, 2016, FDA issued final guidance reflecting its policy on Repackaging of Certain Human (Prescription) Drug Products by Pharmacies and Outsourcing Facilities, first issued in draft form in February of 2015, and blogged here. FDA’s final guidance highlights certain sections because it includes information …
As we previously reported, FDA issued final rules updating the nutrition labeling regulations, 21 C.F.R. §§ 101.9 and 101.36, and the serving size regulation, 21 C.F.R. § 101.12, on May 27, 2016. Despite the rather extensive preamble, the final rules left many questions unanswered. FDA …
On Friday, January 13, 2017, FDA issued two revised interim policies on compounding with bulk substances for Section 503A compounders and Section 503B outsourcing facilities. As you likely recall, FDA’s guidance on use of bulk substances in compounding has had a slow start, in part …
