On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. This came quickly after an announcement was made earlier in the summer that this functionality would soon be enabled for existing users of …
A couple of weeks ago, Senator Durbin and Representative DeLauro introduced the Food Safety Administration Act. The legislation would create the Food Safety Administration (FSA), a food safety agency that would incorporate FDA’s food safety and veterinary medicine centers and the Office of Regulatory Affairs’ …
In its second Orange Book Guidance in as many days, FDA is addressing all of your burning questions about the Orange Book—and boy are we excited at the Agency’s efforts to make the Orange Book accessible for everyone! The Guidance is a Frequently Asked Questions …
The Orange Book’s Therapeutic Equivalence Codes (TE Codes) play a critical role in our drug distribution and payment system. All states have “automatic substitution” laws that require prescriptions to be filled using a generic where available (unless otherwise ordered by the physician), and those substitutions …
Drug pricing has been a hot button issue in the U.S. for decades, and patent protections have been cited as a source of “gamesmanship” allowing brand companies to keep drug prices high. Yet, as long as FDA and FTC have been trying to address anticompetitive …
Last month, the People for Ethical Treatment of Animals (PETA) submitted a petition to the Food Safety and Inspection Service of the U.S. Department of Agriculture (FSIS) requesting that FSIS initiate rulemaking to remove animal raising claims from the label approval process because, according to …
Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. An example of such …
The Build Back Better Act—the food and drug law implications of which we discussed last year—has popped up again in Congress, and it is just as dense as ever. With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. As we explained …
Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. The first relates to the Customer Collaborations Portal (or CCP). As discussed in our prior post on the CCP (here), the CCP is currently a submission tracker providing details of completed and upcoming …
Ten years in the making, a proposed rule was issued by FDA last week that has the potential to bring some prescription drugs that have not been able to gain an OTC approval to retail shelves at long last. Sponsors have been unable to overcome …
On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348). While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to …
