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The pharmaceutical industry is generally satisfied with the EMA’s redesigned post-approval procedures, but would like some clarity on how to tackle more complex filings, according to an EMA survey. Read More
The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products. Read More
The Apothecary Shoppe’s facility in Oklahoma has been given a warning letter after an FDA inspection revealed that the firm produces potassium chloride, a drug that appears on the list of drug products that have been withdrawn or removed from the market. Read More
An FDA review into shipments of drugs from a UK company to the U.S. revealed that Wallace Cameron International has not fulfilled its establishment registration and drug listing obligations but continued to manufacture, prepare, propagate and process drugs that were exported to the U.S. Read More
Pfizer presented results from a global Phase III study of Sutent as an adjuvant therapy following surgery for renal cell carcinoma, showing that it extended disease-free survival by more than one year in patients at high risk for recurrence. Read More