By James E. Valentine* & Alexander J. Varond – Since the breakthrough therapy designation came into existence a year ago, drug companies (and their investors) have been trying to figure out the value of the program. The designation was initially proposed as a way to …
By Kurt R. Karst – FDA’s recent approval of Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco’s”) ANDA No. 077571 for a generic version of PRANDIN (repaglinide) Tablets is interesting on several fronts. For starters, it is the ANDA at the heart of the U.S. Supreme Court’s decision …
By JP Ellison – Last week, John Roth, the Director of FDA’s Office of Criminal Investigations posted on FDA’s blog, FDA Voice. His post concerned a criminal case that had interested us about a Montana resident who had pled guilty and been sentenced on a …
By Kurt R. Karst – In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision …
By Alexander J. Varond – Undoubtedly, most microbes in humans are nonpathogenic, if not beneficial (a.k.a., “good bacteria”). But, since at least the advent of the microscope, humans have shown great hostility toward pathogenic microbes, and relatively little regard for those that are nonpathogenic. Antibiotics are …
By Riëtte van Laack – In a lawsuit filed in federal court, meat industry representatives have challenged the constitutionality of Country of Origin Labeling (“COOL”) regulations as amended by USDA’s Agricultural Marketing Service (“AMS”) in May of 2013. To understand the origin of the lawsuit, it …
By Jennifer D. Newberger & Jeffrey N. Gibbs – In the draft MDR guidance discussed in our prior post, FDA stated that it has not yet issued a Federal Register notice required by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) regarding certain …
By Doug Farquhar – For decades (although not quite since the invention of film), the debate has raged among lawyers who advise clients about FDA inspections: can regulated industry insist that FDA investigators conducting inspections without a warrant put away their cameras, when the investigators try …
By Kurt R. Karst – “… — …” – That’s the international Morse code distress signal commonly shown as SOS. SOS is also in the title of the acronymized “FDA SOS Act,” or the “FDA Safety Over Sequestration Act,” which a bipartisan group of members …
By Joseph W. Cormier – Last week, the Administrative Conference of the United States ("ACUS") made four recommendations to the Executive Branch and independent agencies, three of which may be of interest to readers of this blog. Among its first recommendations this year, the ACUS …
By James E. Valentine* & Anne K. Walsh – Despite Congress giving FDA new powers to regulate the integrity of the drug supply chain, the globalization of the pharmaceutical market continues to present clear challenges for the Food and Drug Administration (“FDA”). FDA’s new authorities …
By Kurt R. Karst – Touchdown! It was just last month that we posted on the first instance in which FDA resolved what has become known as a “180-day exclusivity punt.” As we explained then, “180-day exclusivity punts” are instances in which a first applicant eligible …
It’s that time of year again when we at the FDA Law Blog ask our loyal readers to nominate us for the American Bar Association’s (“ABA’s”) Blawg 100. It’s a list of the top 100 legal blogs – or “blawgs” – in the blogosphere. With …
By Jennifer D. Newberger – At long last, 16 years after the most recent version, FDA has issued a new draft guidance about medical device reporting for manufacturers. Companies have long complained about the ambiguities in the regulation. In a typical case of “be careful what …
By Kurt R. Karst – You know the drill . . . . One organization comes out with a report saying one thing supported by various data. Days later, another organization comes out with a report saying another thing supported by other data. In what …
