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On the administration’s first full workday Monday, President Donald Trump froze federal hiring for most agencies, leaving the FDA with hundreds of job vacancies out of its workforce of approximately 15,000. Read More
Malaysia’s Medical Device Authority (MDA) has established an expedited review process for medical devices already approved in other jurisdictions including the U.S., Canada, Australia, the EU, and Japan. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More