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The FDA and European Medicines Agency (EMA) are extending for two years a pilot program for joint reviews of quality-by-design (QbD) applications, saying the program has helped both agencies develop guidance in this area. Read More
Endo Pharmaceuticals has overcome three complete response letters for its low testosterone treatment Aveed, winning FDA approval for the injectable with a robust risk mitigation program. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said last month. Read More
Government auditors last month criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
The FDA plans to tell drugmakers by the end of November how they should exchange data with supply chain partners to satisfy new federal track-and-trace requirements. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized GMP guidelines. Read More
The FDA has selected 13 drugmakers to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More