The Interagency Food Safety Analytics Collaboration (IFSAC) has issued a strategic plan for the 5-year period beginning in 2017. This is the second such plan issued by IFSAC, a collaboration between FDA, USDA/FSIS, and CDC that aims “to improve coordination of federal food safety analytic efforts …
The American Conference Institute’s (“ACI’s”) 11th annual “Paragraph IV Disputes” conference is right around the corner! The conference will take place from April 24-26, 2017 at the Conrad New York in New York, NY. ACI has put together an excellent program for conference attendees that includes presentations from esteemed …
Cue up Neil Sedaka’s 1962 hit “Breaking Up Is Hard to Do,” or, for some of us younger-minded folk, take your pick from one of many Taylor Swift songs (“We Are Never Ever Getting Back Together,” “I Knew You Were Trouble,” and so many more). What …
It never ceases to amaze this blogger how a law, like the Hatch-Waxman Amendments, can still generate new fact patterns and controversy after more than 30 years in existence! In today’s post, we look at how one of those new issues arose and how FDA …
Litigation between FDA and Ferring Pharmaceuticals Inc. (“Ferring”) over the availability of 5-year New Chemical Entity (“NCE”) exclusivity for Ferring’s colonoscopy preparation, PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535; approved on July 16, 2012), was recently – and quietly …
Antibiotic-resistant bacteria are claimed to be one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). …
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 …
A final regulation implementing the 340B Drug Discount Program has been caught in the regulatory freeze. In the waning days of the Obama Administration, the Health Resources and Services Administration (“HRSA”) of HHS issued a final regulation describing the methodology for calculating the 340B ceiling …
On Monday, March 27, FDA and the Society of Toxicology (SOT) will present a colloquium (chaired by Bernadene A. Magnuson, PhD, Health Science Consultants, Inc., and Sabine Francke, DVM, PhD, CFSAN FDA) on Considerations for the Determination of Adversity in Food Chemical Safety Evaluations, the …
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 …
Oh Canada! Congress has decided that it’s once again time to start looking to our neighbors to the north for some help increasing accessibility and decreasing cost of prescription drugs. With two new bills introduced in the last month, one in each chamber of Congress, …
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 …
On March 14, in the Federal Register, FDA published a list of Class II devices that the agency proposes exempting from the 510(k) requirements. A copy of the Federal Register notice can be found here. As you may recall from our earlier post, Section 3054 …
On Friday, Amgen submitted its Opening and Response Brief at the Supreme Court in the matter of Sandoz v. Amgen, Nos. 15-1039, 15-1195. The brief addressed two major questions with respect to the BPCIA: when an applicant can provide 180-day notice of biosimilar marketing and …
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 …
