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The Generic Pharmaceutical Association (GPhA) has proposed a program that would allow pharmaceutical companies with secure supply chains to avoid last-minute delays when importing Rx products at U.S. ports.
The UK’s Serious Fraud Office (SFO) said it plans to levy criminal charges against five generic drug companies for conspiring to defraud the British National Health Service (NHS) by fixing the prices of blood-clotting and antibiotic drugs.
The FTC has asked Cephalon for information about settlements it made with four generic drug firms allowing them to market generic versions of Cephalon’s narcolepsy drug Provigil, according to documents filed with the SEC.
The biotechnology sector is making a final push to ensure the SEC adopts recommendations to exempt smaller companies from financial reporting and auditing requirements, alleging these standards create burdens that will stunt innovation.
Only four study-data tabulation model (SDTM) submissions to FDA's Janus cross-trial database had been received as of December, but many hope the lure of swifter regulatory approvals, thanks to the project's use of Clinical Data Interchange Standards Consortium (CDISC) standards, will bring in 10 or more by June.
The FDA is expected to make a decision in May about whether to implement long-delayed pedigree requirements for drugmakers to combat counterfeit prescription drugs, according to a top agency official.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, Page 1).
Pfizer has filed a citizen petition asking the FDA to recall generic versions of its antibiotic Zithromax, made by Teva Pharmaceutical and Sandoz, on grounds the generic labels do not accurately describe the drug’s active ingredients.