Why This Massachusetts Synthetic Bio Startup Could be the Next Biotech Unicorn
In investment jargon, a "unicorn" has at least two meanings. Source: BioSpace
FDA Hits Glenmark for Quality Controls, Complaint Handling
The FDA cited a Glenmark Pharmaceuticals facility in Solan, India for failing to investigate discrepancies, inadequate complaint records and improper maintenance of quality data. Source: Drug Industry Daily
FDA’s Complete Responses to Generic Drugmakers Continue to Outpace Fiscal 2017
The FDA continued to issue a larger number of complete response letters to generics manufacturers last month — dropping from a spike in October, but still higher than any single…
PhRMA Sues California to Block Law Requiring Advanced Notice of Price Hikes
PhRMA filed a lawsuit against the state of California challenging its newly signed law meant to stem rising prescription drug prices. Source: Drug Industry Daily
FDA Finalizes Guidance on Product Name Placement in Advertisements
The FDA finalized its guidance on drug advertisements, clarifying the legal requirements for companies in the placement of the product’s name — as well as its size, prominence and frequency…
483 Roundup: Three Firms Cited for Labeling, Complaints, Safety Problems
The FDA flagged three U.S. facilities for a variety of noncompliances observed by agency investigators during inspections, including issues with labeling, failure to properly handle complaints and reporting of adverse…
EEA Third-Country GMP Inspections Drops in 2016
Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of…
Morrison Says ORA Reorganization Will Mean More Foreign Inspections
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Source: Drug GMP Report
Warning Letter Roundup: FDA Flags Labeling, Sterility, Other Violations
The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Source: Drug GMP Report
FDA Details Product Tracing Exemptions Under the DSCSA
The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Source: Drug GMP Report
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