The FDA is making good on their promise. The dollars generated from GDUFA fees are funding the increased scrutiny of overseas generic drug suppliers. As a result, the quality of many finished dosage companies are making headlines, as exampled below. Medicines Made in...
One year after the implementation of GDUFA, the FDA has met their timeline by providing guidance on enhanced Refusal-to-Receive standards for ANDAs and related submissions. The Guidance for Industry ANDA Submissions – Refuse-to Receive Standards, published October...
Escape Hatch: New Legislation Seeks to Provide a Way Out for Some Companies Subject to GDUFA User Fees Article published on FDA Law Blog, December 2013 Possible Good News for Smaller Generic Drug Manufacturers: The Small Manufacturer Protection Act of 2013 proposing...
December 2013 Woodbridge, CT/China – ChemWerth Inc. is pleased to announce two more successful overseas FDA audits in October. This adds up to 53 successful inspections in the past 5 years facilitated by ChemWerth. “We are particularly pleased with the most recent...
3-5 December 2013 One World. One Quality. One Company. ChemWerth is attending CPhI India and we would love to see you there. Join us December 3rd – 5th at the Bombay Convention and Exhibition Centre, Mumbai, India – Hall #1, Stand M32. Our Goal: To foster existing...
One World. One Quality. One Company. ChemWerth is attending CPhI Worldwide and we would love to see you there. Join us October 22nd-24th in Messe, Frankfurt, Germany in the Custom Manufacturing Hall at Chemcon Booth 50C70. Our Goal: To foster existing partnerships and...
