As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Interest rates may be on the way down, which in turn may …
The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). It is the latest item on a long list of similar initiatives that have marked 2023. Those efforts add up to …
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 …
The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Among its top priorities, OPQ’s Director Mike Kopcha has recently said that OPQ is focused …
As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court. Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in …
The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the …
As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge …
Sentencing for defendants convicted in federal court of felony offenses that involve fraud, including violations of the Federal Food, Drug, and Cosmetic Act, may be dramatically reduced based on an opinion issued last week by a panel of the Third Circuit Court of Appeals. The …
