As an avid reader of OPDP Warning and Untitled Letters that routinely allege pharma companies have engaged in false or misleading Rx drug promotion, this blogger read with interest FDA’s press release on its crackdown on deceptive DTC drug advertising. As I dug into the …
Commissioner Makary’s pronouncement in April of a new pathway for rare disease therapies based on a plausible mechanism of action or biological plausibility generated enormous excitement. The Commissioner’s general statement found meaningful expression in twin announcements this past Wednesday: one by Dr. Tidmarsh of a …
Yesterday, FDA announced the publication of 89 previously unpublished Complete Response Letters (“CRLs”), which appears to be the next step in FDA’s effort towards “radical transparency.” The first step was the posting of 200 already-published CRLs on July 10, 2025, which we blogged about here. …
FDA’s recent approval of Papzimeos (zopapogene imadenovec-drba) highlights FDA’s use of regulatory flexibility in rare, serious diseases with unmet medical need. Approved on August 14, 2025, Papzimeos is the first treatment in the U.S. for recurrent respiratory papillomatosis (RRP), a rare disease characterized by recurrent …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce speakers for the program we are co-hosting with Freshfields geared toward early-stage biotech and medtech companies. This program will be a half-day, in-person event at Freshfields’ Silicon Valley office on Wednesday September 10, 2025. HPM’s Michelle …
As the summer of 2025 comes to a close and we begin to look toward to the 2026 Fiscal Year, FDA is completing its reporting on 2024. The FDA’s fiscal year 2024 Report on the State of Pharmaceutical Quality from CDER’s Office of Pharmaceutical Quality …
CDER’s Office of Pharmaceutical Quality (OPQ) recently published a white paper called Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective. Not entirely a financial analysis, OPQ is making what amounts to a two-part sales pitch to pharma execs that investment in manufacturing quality …
Hyman, Phelps & McNamara, P.C. (HPM) is excited to announce a program that we are co-hosting with Freshfields geared toward early-stage biotech and medtech companies. This program will be a half-day, in-person event at Freshfields’ Silicon Valley office on Wednesday September 10, 2025, and will feature …
Boston was once again the hub for female leadership in life sciences law this summer as attorneys, executives, and policymakers gathered for the 12th Annual American Conference Institute (“ACI”) Women Leaders in Life Sciences Law Summit on July 30–31, 2025. Hosted at the Seaport Hotel, the …
One familiar with homeopathy might reasonably think that the practice would have a place in the Make America Healthy Again movement as an alternative to conventional pharmaceutical treatment. But after a recent court decision issued on July 15, 2025, the regulatory path for homeopathic medicine …
We blogged recently about the new Commissioner’s National Priority Voucher (“CNPV”) program, noting that we were eagerly awaiting additional details. On July 22, 2025, FDA announced some of these additional details and opened the CNPV program for applications. These additional details are to be found on …
The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (here), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. One amendment would add provisions for bundled sales that are consistent with …
On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025. Under the titular theme “Ensuring Accountability and Prioritizing Public …
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 …
