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FDA’s Guidance on Placebos
The FDA finalized guidance regarding the use of placebos and blinding during randomized cancer trials. The guidance finalizes a draft made in 2018 and clarifies scenarios where placebo designs and blindings should be...
FDA Shifts from QSR and ISO 13485
  The FDA will shift from QSR to ISO 13485 so that their system regulations can harmonize with international practices to reduce confusion and and lessen the burden for medical device manufacturers.   What is QSR...