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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.
The FDA issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children.
A recently published U.S. Food and Drug Administration (FDA) guidance provides detailed information on what firms need to include in premarket notification, or 510(k), applications for cord blood processing systems and storage containers.
Health Canada has published final guidance for manufacturers on how and when to submit pharmacogenomic (PGx) information in support of an application for a medical device, drug or biologic product intended for human use.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a device bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices.
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.
The FDA issued a final guidance giving recommendations on how to design, conduct and evaluate clinical studies looking at the effects of corticosteroids on growth in children.
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.