During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.
The FDA conducted a total of 18,034 inspections in FY2019, off which 6,434 were inspections of biologics, medical device, or drug companies. Those inspections resulted in the issuance of 15,015 warning letters, a slight increase over 2018. The FDA also increased its import alerts, publishing 98 in 2019. This corresponded with a decrease in injunctions and seizures, showing the FDA’s preference for earlier preventive measures over later involvement.
Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the “Drug Shortages: Root Causes and Potential Solutions” report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.
FDA requirements and compendial standards for pharmacy compounding and outsourcing continue to evolve, and the FDA has different requirements for products prepared through pharmacy compounding practices as compared to those manufactured for use in clinical studies.
Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.
In Oct. 2019, the FDA’s Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report’s findings and discusses potential next steps the FDA may take.
Although the development of cancer drugs for children is riddled with challenges, the requirements in Section 504 of the FDA Reauthorization Act of 2017 (FDARA) represent a significant paradigm shift in pediatric oncology. Effective in August 2020, the act also ended an existing exemption for oncology drugs with orphan status and stipulated numerous statutory requirements for the agency itself.
This article presents the most recent publication of GMP drug inspection data from CDER, published November 15, 2019 and addressing drug inspections conducted in FY2019. We’ll also take a look at seven years’ worth of trends in drug GMP inspections.
New drug approvals are on the way up, as the FDA approved 11 percent more innovator therapies in 2018 compared to the previous year, spelling good news for both marketing authorization holders (MAHs) and CMOs. Data also shows that small- and mid-cap pharma companies are increasingly turning to outsourcers to manufacture newly approved drugs.