JD Supra8m
AI-Enabled Device Software Functions: FDA’s Final Guidance for Predetermined Change Control Plans
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) ...
Hosted on MSN30m
Cat food recalled in Massachusetts after testing positive for salmonella. What brand
Cat food is being recalled for possible salmonella contamination. The Food and Drug Administration (FDA) recently issued a ...
JD Supra35m
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
FDA Limits Toxic Lead in Some Baby Foods
The agency issued final guidance that it estimated could reduce lead exposure from processed baby foods by about 20% to 30%. The limits are voluntary, not mandatory, for food manufacturers, but they ...
BioSpace39m
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
FDA approves first ever medication for obstructive sleep apnea — here's what that means
The US Food and Drug Administration has approved the first ever prescribed medicine for Obstructive Sleep Apnea. Read on to ...
Quality Assurance55m
FDA Issues Final Guidance on Action Levels for Lead in Processed Food Intended for Babies, Young Children
The final guidance covers packaged processed foods that are represented or purported to be for babies and young children less ...
BioSpace58m
Big Pharma Rushes to China for Deal Prospecting Despite Regulatory Uncertainty
China is adapting its Life Sciences policy to bolster innovation and data transparency. Big Pharma is taking note.