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The FDA has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
Healthcare providers and other "covered entities" must regularly improve their data security policies and procedures to be in compliance with the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.
New guidance documents prepared by three study groups of the Global Harmonization Task Force (GHTF) should help smooth the way for more expedited device approvals and ease firms' ability to comply with foreign regulations.
The FDA’s proposal to regulate complex genetic laboratory-
developed tests (LDTs) could stifle the development and marketing of new diagnostics, presenters said at a recent public meeting.
The FDA’s proposal to regulate complex genetic laboratory-
developed tests (LDTs) could stifle the development and marketing of new diagnostics, presenters said at a recent public meeting.
South Africa’s Medicines Control Council, a division of the Department of Health, has issued final guidance on how and when to submit information related to changes to drugs listed in the country’s medicines register.
The European Medicines Agency (EMEA) has issued guidance addressing questions that users of the agency’s “New Framework for Scientific Advice & Protocol Assistance” may have.
The FDA is exempting drugs that will be used for the President’s Emergency Plan for AIDS Relief (PEPFAR) from Prescription Drug User Fee Act fees to lessen the financial difficulties associated with developing the products, an agency guidance says.
Medical device firms should establish special controls to ensure the safety and effectiveness of quality control (QC) materials for cystic fibrosis nucleic acid assays, according to U.S. Food and Drug Administration (FDA) guidance published Jan 10.