Dr. Jeffrey Shuren—Director of the FDA’s CDRH (Center for Devices and Radiological Health)—in the latest release stated that since medical device production has become a progressively global enterprise, the agency has taken powerful action to raise inspections of medical device organizations. The actions are being taken especially for the companies who are situated in foreign countries.
Dr. Shuren stated that over the last decade, the agency has increased the number of international device inspections by 243% yearly considering that quality system problems are more possibly to occur in organizations located overseas. This increased lapse has caused giving tangible results, as published in the latest “Medical Device Enforcement and Quality Report.” Dr. Shuren further added that today’s report also cites outcomes from a lead initiative the agency launched this year by using a third-party system to give an appraisal or assessment of an organization to decide if there are any breaches in quality systems or manufacturing processes. This appraisal program is crafted to advance manufacturing processes, quality, and has led to 32 appraisals relating 18 manufacturers who accounted tremendously that the appraisal had an optimistic impact on the superiority of their devices. These attempts are another revelation of the agency’s assurance to make sure medical devices are effective and safe throughout the whole product lifecycle.
Recently, the FDA was also in news as one pharmaceutical company seeks approval for independently developed epilepsy drug. SK Biopharmaceuticals—an member of South Korean SK Group—has applied NDA (new drug application) with the U.S. FDA for the company’s cenobamate, a new drug to cure epilepsy. It is the first time ever for a Korean company to apply the FDA with an independently developed new drug. The application is based on information from Phase II and Phase III clinical trials to reveal the drug’s safety and efficacy profile in over 2,400 patients with partial seizures.