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This week, the FDA issued rules on new device classifications for SARS-CoV-2 detection devices, devices that detect select microbial agents and some intravenous catheter separation devices. The agency also announced a public meeting to discuss establishment of a Rare Disease Innovation Hub and is seeking comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. HHS published a proposed regulatory agenda. Read More
Omega Tech Labs received an FDA Warning Letter for inadequate procedures to prevent microorganisms in its combination product and failure to meet water quality standards in manufacturing following a Jan. 17-22 inspection. Read More
Amgen filed a lawsuit against Samsung Bioepis for infringing 34 patents that cover denosumab, the active ingredient in Prolia and Xgeva, drugs used to treat bone loss. Read More
Novartis’ 2022 complaint against several generic drugmakers for allegedly infringing on a patent for its blockbuster heart failure drug Entresto (sacubitril/valsartan) was denied on Tuesday, but the judge gave the company a stay in the order to allow it to appeal in federal court. Read More
From a warning that the new pricing scheme doesn’t mean patients are protected from increased costs to another that the Inflation Reduction Act (IRA) pricing scheme will limit patients’ access to medicines now and in the future, big pharma has expressed its displeasure with the public unveiling of prices. Read More
The FDA is inviting comments, for consideration by WHO, concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight narcotic drugs. Read More
Ensuring that laws such as the Inflation Reduction Act (IRA) do not have unexpected consequences or diminish patient-centric innovation requires a clear-eyed view of the way that legislation operates in the real world, the Biotechnology Innovation Organization (BIO) said in response to two studies conducted by Bentley University. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, a WCG Clinical company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
After a bumpy road to approval, the FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 66 pounds. Read More
The FDA has issued two new guidances on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer. Read More
A study of trends in prescriptions dispensed at retail pharmacies for semaglutide showed a 442 percent increase in fills between January 2021 and December 2023 — increasing from 659,000 to 2,270,564 during that time period, according to a recent study. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More