Top Industry News
- Swiss eCTD: Updating of Module 1 as of January 2019
- SFDA- Top Deficiencies in Phase II Validation
- Health Canada is pleased to announce the second publication of the Guidance Document: Certificate of Supplementary Protection Regulations
- TGA- Certificates of free sale and export certificates for medical devices
- ANVISA consolidated the preliminary results of a Public Feed of Subsidies (TPS) on nutritional labeling of foods
- FDA seeks comment on declaring live microbials in colony forming units (CFUs) on the Supplement Facts label
- ANVISA will adopt a new format for publication of acts in the Official Gazette of the Union (DOU), regarding records and registrations of medical devices
- EMA- Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (updated)
- FDA- 510(k) Reviews: FDA Launches 'Quik' Pilot
- FDA to launch new program to help advance innovation by promoting greater efficiency and consistency in review of certain moderate-risk medical devices
- CDSCO- Draft Guidance Document for Medical Devices
- FDA advances framework for handling uncertainty in assessments of medical devices to improve consistency and transparency during pre-market review
- FDA Clarifies Policies on Acceptable Levels of Uncertainty for Devices