Tag:
Cgmp Regulations
Latest Headlines
Latest Headlines
Forecast: Pharma wants CMO consulting, regulatory support
For 2012, contract manufacturers should brace for an increase in requests for bioanalytical testing, consulting, high-potency compound and regulatory support services. But they should be able to
Woodcock: More predictable manufacturing may ease regulations
Drug manufacturing experts from the 1950s would have no trouble recognizing today's manufacturing processes, according to the FDA's Janet Woodcock. But that will change as batch processing gives way
FDA probes SPL over contaminated heparin
The FDA is still investigating Scientific Protein Laboratories over a case of contaminated heparin that occurred after the headline-grabbing Baxter recall of the blood thinner in 2008. The initially
Hong Kong to toughen regs
Sound familiar? Following several drug "incidents," Hong Kong is beefing up its drug regulatory arm. Although a nine-month investigation finds that the existing framework is "sound and should be
FDA tackles combo confusion
The on-again, off-again efforts of the FDA's office of combination products are back on again. The OCP's good manufacturing practices proposal is intended to clarify confusion surrounding approvals
