Warning Letter Roundup: FDA Warns Devicemakers for Unapproved Tests
The FDA issued warning letters to four device firms for violations that included unapproved tests and quality failures. Source: The GMP Letter
TGA Reports Harm Caused by Medical Software
Australia’s TGA reported finding clear examples of harm caused by medical software in a review of medical device recalls. Source: The GMP Letter
FDA Resumes Domestic Inspections Using New Risk Assessment System
FDA Commissioner Stephen Hahn said that the agency is resuming domestic inspections using a new risk assessment system developed in response to the pandemic. Source: The GMP Letter
MedTech Europe Pushes for Virtual Audits Under MDR/IVDR
MedTech Europe is urging the European Commission and EU member states to publish guidance that clarifies that notified bodies may conduct audits virtually in place of on-site audits during the…
EMA Posts Five-Year Drug Regulatory Strategy for Comment
The European Medicines Agency (EMA) has issued a proposed five-year pharmaceutical regulatory plan with six areas of focus including improvements in the drug supply chain. Source: Drug GMP Report
FDA Extends Enforcement Discretion Deadline for Regenerative Medicines
As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the…
FDA Releases Spring Regulatory Agenda
The FDA released its spring regulatory agenda for proposed and final rulemakings, including the following planned actions: Source: Drug GMP Report
483 Roundup: Five Firms Cited for Quality Failures
The FDA issued 483s to five drugmakers for inadequate good manufacturing practices observed by agency investigators during inspections of their facilities. Source: Drug GMP Report
Warning Letter Roundup: FDA Raps Four Drugmakers for Quality Lapses
Four drugmakers drew warning letters from the FDA for quality failures including testing and other deficiencies. Source: Drug GMP Report
FDA Expands Guidance on Pregnancy and Lactation Labeling
The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling. Source: Drug GMP Report
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