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The FDA has made significant revisions to a November 1999 guidance that provides recommendations on the types of drug impurity data included with drug applications.
The FDA released a draft guidance Jan. 25 providing recommendations on nonclinical safety evaluations to support the clinical study and approval of drug combinations, including fixed dose combination products, co-packaged products and adjunctive therapies.
Roche will begin posting results from key clinical research studies online by the end of the first quarter of fiscal 2005, the company announced Jan. 21.
In a move that could boost the market for HIV drugs, the Centers for Disease Control and Prevention (CDC) has issued revised guidelines recommending that physicians provide antiretroviral drugs to patients exposed to HIV from rapes, accidents, injection-drug use or unsafe sex.
Manufacturers of self-expanding and balloon-expandable extracranial intravascular stents should submit their nonclinical test protocols to the FDA before conducting any tests, the agency recommended in a recently released guidance document.
The FDA’s Center for Devices and Radiological Health released a question-and-answer guidance document intended to clarify how 21 CFR Part 820 of the quality system (QS) regulation applies to software maintenance activities for networked medical devices.
The FDA and Centers for Medicare & Medicaid Services (CMS) will increase their postmarket surveillance activities to collect "invaluable information" on the use of medical products in the real world, according to an HHS task force report that examined ways to better coordinate activities across the department and to streamline the way HHS does business.
The Combination Products Coalition (CPC) intends to submit a draft report to the FDA with recommendations on how FDA intercenter agreements can be modified to better define roles and responsibilities for handling approvals, modifications and preapproval inspections for combination products.
The FDA has reopened the public comment period for two International Conference on Harmonisation (ICH) draft guidances that assess possible cardiac risks associated with new drugs.
The FDA has issued a draft guidance to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC “Drug Facts” format.