In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. These particular CRLs were issued in response …
Recently, FDA announced a deadline shift, although the Agency did so quietly. On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently …
Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced (here and here) the release of a report, titled “Assessment of the Impact of Settlements,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and …
Last Friday, the Supreme Court delivered a trio of decisions making it easier to litigate against the federal government. The facts and law in each case matter, and as is often the case when the Supreme Court “decides” an issue, much remains to be seen. …
After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. As described in the …
Thirty two years ago today, on June 10, 1993, Congress passed the landmark National Institutes of Health (NIH) Revitalization Act to remedy historical exclusion of women and minorities from research participation. The law directed the NIH Director to ensure the inclusion of women and minorities …
Among other things, EO 14212 established the Make America Healthy Again (MAHA) Commission (with HHS Secretary Kennedy as its Chair) and tasked it with a tall order: submission to the President of an Assessment that tackled 10(!) complex public health issues within 100(!) days. Perhaps …
In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Senator Dick Durbin (D-IL) expressed concerns over the agency’s ability to regulate direct-to-consumer (“DTC”) prescription drug advertisements following recent workforce reductions. In his letter, Senator Durbin highlighted FDA’s critical role in ensuring that pharmaceutical …
In yet another installment of the drama that is Jazz v. Avadel, the Federal Circuit recently reviewed a decision from the U.S. District Court for the District of Delaware that addressed the scope of an injunction under the patent safe harbor imposed on Avadel’s Lumryz …
FDA recently announced, “CEO Forums: An FDA Listening Tour to Engage Pharma CEOs.” These are scheduled to take place in several cities on both coasts in June and July (here).” This tour to engage with pharmaceutical and biotech CEOs is unprecedented. According to the announcement, Commissioner …
On May 21, FDA announced “enhancements” to the Section 804 import program (SIP). Section 804 of the Federal Food, Drug, and Cosmetic Act provides a pathway for certain prescription drug imports from Canada. The FDA news release provides that FDA is offering to pre-review SIP …
Following up on Donald Trump’s May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health and Human Services today issued a brief press release answering a few of the multitude of questions raised by the Executive …
Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institute’s Annual Conference, continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Now firmly in the chair after the agency’s controversial RIFs—which he …
In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology (“AMT”) designation from FDA. The designation was granted by CBER to Cellares for its automated cell therapy platform, the Cell Shuttle. We were excited to see the news and …
We are still parsing through the May 12 Executive Order (EO), “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” and impacts this may have on the pharmaceutical industry. We’ve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 …
