We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Heavy reliance on foreign manufacturing for essential medicines is at the root of FDA concerns over supply chain and drug shortages, according to a report from the FDA Office of Pharmaceutical Quality (OPQ) that shows 82 percent of API and 57 percent of finished dosage form manufacturing sites are outside the U.S. Read More
The International Council for Harmonisation’s (ICH) governing group announced earlier this month it will begin work on new guidelines in three areas: patient preference, nonclinical safety evaluation for oligonucleotide-based therapies and bioequivalence for modified-release products. Read More
To better understand the performance of the in vitro diagnostic tests used to identify the right treatment for cancer patients, the FDA has begun a pilot project for CDER-regulated oncology drugs and the corresponding clinical assays. Read More
Bristol Myers Squibb (BMS) filed suit against HHS and CMS over the Inflation Reduction Act (IRA) claiming that the drug price negotiation program violates the Constitution by “forcing pharmaceutical companies to turn over their most successful and innovative products at a huge discount.” Read More
The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device and biologics products. Target release dates vary by rule. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a seven-page untitled letter informing Xeris Pharmaceuticals that its website advertising the drug Recorlev (levoketoconazole) makes “false or misleading claims and representations about the safety and efficacy” of the tablets. Read More
FDA’s method for assessing requests for major-to-minor reclassifications for complete response (CR) letters is described in the just-released Manual of Policies and Procedures (MAPP). Read More
Drugs or indications should not “maintain approval if confirmatory studies fail, even while additional confirmatory studies are pursued,” the researchers say. Read More
Several chambers of commerce have sued HHS and CMS over the Inflation Reduction Act (IRA) claiming that the prescription drug price control program is “a violation of America’s fundamental constitutional requirements of limited government, property rights, the rule of law, and the separation of powers.” Read More