For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment …
Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent …
I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. While it has been long established that FDA-approved or mandated labeling preempts state failure-to-warn claims, some courts have decided that sometimes labeling just isn’t …
We need to talk about nitrosamines. Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What are nitrosamines? Nitrosamines are chemicals that can form during drug manufacturing, known …
Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue …
One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before, that distinction is critical to assigning a particular product to the …
Well, it’s official: The Federal Circuit decision in GSK v. Teva stands, as the Supreme Court has decided not to hear the case on appeal. While the statistics were against the Supreme Court taking up the case given the limited number of cases heard per …
Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of …
FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As the Office of Generic Drugs (“OGD”) has stated, “[t]he clarity and transparency provided by PSGs help streamline generic drug product development, …
FDA has not been shy about its distaste for the Catalyst decision; the Agency has published on its website the litany of problems that arise from it and has sent emails and letters to stakeholders essentially urging them to contact Congress to address the decision. …
Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) …
In the wake of President Biden’s July 2021 Executive Order—Promoting Competition in the American Economy—and the exchange of letters between the Patent and Trademark Office (USPTO) and FDA, the USPTO announced recently a “public listening session” in collaboration with FDA to seek comments on how …
FTC sure thinks so. And the FTC said as much in a recent Amicus Brief (“Brief”) in paragraph IV litigation between Avadel CNS Pharmaceuticals (“Avadel”) and Jazz Pharmaceuticals Inc. (“Jazz”). This type of statement from the FTC is unprecedented; not only is the FTC Brief …
After 5 long years, FDA has finally adopted the long-awaited OTC hearing aid rules. While the Proposed Rule was a year and a half overdue, FDA impressively turned out the Final Rule about 7 months after the close of comments on the Proposed Rule, which …
For years, FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions. One of those pressing questions that remains unanswered involves the listing …
