One and a half years since FDA first proposed changes, two months since the final rule was published, one month after objections threatening an Administrative Procedure Act challenge, and one day before the rules would have taken effect, FDA announced on Monday that it would …
On March 15-17, 2017, the American Society for Experimental Neurotherapeutics (ASENT) held its 19th Annual Meeting in Rockville, MD. The meeting brought together clinical investigators, pharmaceutical industry sponsors, officials from drug regulatory agencies, and patient advocacy organizations to address and advance the science of neurotherapeutics. On …
There are many things that are unique to the 505(b)(2) NDA approval pathway. Some are good and some are . . . well, let’s just say that they have proven to be frustrating for some 505(b)(2) applicants. Perhaps one of the most nettlesome aspects of …
The U.S. Government Accountability Office (GAO) recently issued a January 2017 report to the Senate Committee on Health, Education, Labor, and Pensions. The GAO report examines: The steps FDA has taken to encourage the development of antibiotics to treat serious or life-threatening infections since the enactment …
Periodically, legislators and others become concerned about reports citing the high price of some orphan drugs, including drugs that achieve blockbuster status (earning more than $1 billion a year). Several proposals have been introduced in response to such concerns. In 1990, Congress passed legislation that …
We recently blogged about whether FDA’s recent amendment to the intended use regulation could be considered essentially null and void based upon a failure to comply with the Congressional Review Act. Apparently, this suggestion caused quite a stir and even excitement in some quarters, as it …
A few weeks ago, we blogged about FDA’s final rule amending the “intended use” regulation. The final rule looks very different than the proposed rule, and adopts a new “totality of the evidence” standard that does not resolve the old problems with the regulation but …
In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 29th iteration, is back in New York at the Millennium Broadway Hotel on March 22-24, 2017. The conference is billed as the premier event to provide folks with a roadmap to navigate the …
FDA recently released a report summarizing its enforcement activities for FY 2016 (October 1, 2015 to September 30, 2016). It shows, among other things, that the number of warning letters from the Center for Drug Evaluation and Research doubled (76 in FY 2015 to 151 …
It was just a couple of weeks ago that we published a post titled “Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a ‘Route of Abuse’ Approach to Exclusivity.” Among other things, we discussed Egalet US, Inc.’s ARYMO ER (morphine sulfate) Extended-release Tablets, …
On Inauguration Day (January 20, 2017) President Trump’s assistant Reince Priebus circulated a regulatory “freeze order” blogged here affecting regulations and guidance published in the Federal Register but that had not yet taken effect, postponing their effective date for 60 days (from January 20, 2017). The …
In 2015, FDA proposed revising the so-called intended use regulation (21 CFR 201.128; id. § 801.4) to remove the famous “knowledge” sentence: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce …
2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on …
On January 18, 2017, the U.S. Department of Health and Human Services along with 15 other federal agencies issued the Final Rule to revise the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” This 1991 set of regulations created a …
