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Health Canada has published a revised keyword index aimed at helping medical device manufacturers determine the appropriate classifications for their products.
Health Canada’s Medical Devices Bureau posted an updated guidance Sept. 22 on the recognition and use of safety, efficacy and labeling standards under the Canadian Medical Devices Regulations.
Medical test manufacturers should look for two recent FDA draft guidances: one covering a new type of medical test called in vitro diagnostic multivariate index assays (IVDMIAs), and the other clarifying the rules for commercially distributed active ingredients of medical tests called analyte specific reagents (ASRs).
The FDA is seeking to help the pharma industry adopt modern quality management system principles so that companies can produce drugs more efficiently, lower costs and prevent shortages through a new guidance released Sept. 29.
The FDA is seeking to help the pharma industry adopt modern quality management system principles so that companies can produce drugs more efficiently, lower costs and prevent shortages through a new guidance released Sept. 29.
The FDA is withdrawing three electronic new drug application (NDA) and abbreviated new drug application (ANDA) guidances because the agency wants companies to adhere to a single format for submissions.
The FDA issued a new guidance Sept. 28 to help makers of cell-based viral vaccines improve the development and availability of vaccines, including those to address emerging and pandemic threats.
The FDA will now immediately post new drug, abbreviated new drug and biologics license application amendments online to improve electronic access to drug information, the agency says.
To help device firms remain in compliance with Medicare and Medicaid regulations, AdvaMed is asking HHS' Office of Inspector General (OIG) for clearer guidance on physician investments in firms that make or distribute devices.