Howard Sklamberg Quoted by Bloomberg BNA on FDA’s New Drug Facility Inspection Process
Akin Gump health partner Howard Sklamberg has been quoted in the Bloomberg BNA Pharmaceutical Law & Industry Report article “FDA Puts Heads Together to Streamline Drug Facility Inspections,” regarding steps being taken by the Food and Drug Administration to improve its oversight of drug manufacturing.
The article reports that the FDA’s Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs and reviews new drug applications, and Office of Regulatory Affairs (ORA), the lead office for all agency field activities, are implementing a new agreement to collaborate more fully on drug manufacturing facility inspections and evaluations. The goal is to make more efficient use of the FDA’s resources, while allowing for better communication with drug developers.
Sklamberg, a former FDA Deputy Commissioner for Global Regulatory Operations and Policy, said he thinks the agreement will speed up the FDA’s inspection and review process. He said it ensures the relevant decision makers in the ORA and CDER are “on the same page at the very beginning of the process and that they’re sharing notes and exchanging their thoughts early on rather than what would have been done in the past. It’s better for everybody, the agency and industry, if those conversations happen earlier.”