To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA) ...
The new diagnostic criteria automatically categorize anyone with abnormal levels of beta amyloid or tau as having Alzheimer’s disease.
Learn from a prominent regulatory expert how to optimize your LDT applications to help secure a 510k clearance or premarket ...
The Mark Cuban Cost Plus Drug Company is offering a low-cost, imported penicillin product after being given temporary approval by the FDA to help ease the ongoing shortage of Pfizer’s Bicillin L-A, a ...
Sterile drugmakers seeking to comply with new EU GMP guidelines introduced in August 2023 should consider an in-depth gap assessment in their facilities — working through the guidelines line by line, ...
FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...
The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to ...
FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...
FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...
FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...
FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...
The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset ...