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The FDA recently issued warning letters to two Asian manufacturers found to be in violation of current good manufacturing practice (cGMP) requirements.
The FDA proposed rule changes May 6 critical to determining which agency product center takes the lead on regulatory oversight of a particular combination product.
Roche stated last week that it has completed the integration of troubled Disetronic Medical Systems into its operations and is making preparations for an FDA re-audit to resolve good manufacturing practices (GMP) deficiencies discovered within the subsidiary.
Boston Scientific revealed late last week that it intends to make slight alterations to its high-profile Taxus drug-eluting stent system to address reports that surgeons have had difficulty withdrawing balloons used to place the devices in patients.
While it’s still too early to tell what regulatory course Daniel Shultz will take in his tenure as acting chief of the FDA’s Center for Devices and Radiological Health (CDRH), he told D&DL last week that he doesn’t plan to stray far from the path that his predecessor, David Feigal, blazed.
The FDA's Center for Biologics Evaluation and Research (CBER) plans this year to develop a template for reviewing proposed products, implement a formal training program for reviewers and create more opportunities for biotech firms and other stakeholders to provide input on efforts to enhance the development of new products.
An FDA advisory panel last week recommended that the agency reject a new drug application (NDA) for the cancer drug Genasense, saying the clinical trial data submitted in support of the application did not offer substantial evidence of the drug’s efficacy.
U.S. trade officials say they are concerned about the lack of adequate protection for test data submitted by drugmakers to health authorities in countries such as Israel and Turkey, according to a new report on international intellectual property (IP) protections by the Office of the U.S. Trade Representative (USTR).
Bush administration officials likely violated federal law by allegedly trying to prevent the chief actuary at the Centers for Medicare & Medicaid Services (CMS) from releasing cost estimates on last year’s Medicare drug bill, according to the Congressional Research Service (CRS).