Moderna Will Evaluate Booster Shot for COVID-19 Vaccine in New Trial
Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in…
FDA Recommends Labeling Update for Laparoscopic Power Morcellators
The FDA has issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue…
483 Roundup: Inspections Reveal Lapses at Five Device Facilities
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Source: The GMP Letter
EU Launches First of Six Eudamed Modules
The European Commission (EC) launched a new registration module in December for Eudamed, the EU database that will be used to monitor the safety and performance of devices under the…
How Post-Brexit Changes Will Impact Devicemakers
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not…
FDA Continues to Target Unapproved COVID-19 Tests
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this…
EU Clarifies Expectations for Remote Audits
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Source: The GMP Letter
FDA Publishes Two Guidance Documents on Naming New Drugs
FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors.…
483 Roundup: FDA Raps Four Facilities for Quality Failures
FDA inspections revealed good manufacturing practice and other deficiencies at drug manufacturing facilities in New Jersey, Vermont and California, leading to Form 483 inspection observations for four firms. Source: Drug…
FDA Limits Controlled Correspondence Options for Generic Drugmakers
A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Source:…
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