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India’s CDSCO issued answers to frequently asked questions on its new medical device rules and said licenses granted after Jan. 1, 2018 will remain valid indefinitely. Read More
The agency is adding requirements for statements of compliance with FDA regulations covering human subject protection and institutional review boards. Read More
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More