FDA Accuses Two Foreign API Makers of Data Integrity Lapses
The FDA has accused two foreign API makers of data integrity practices in recent warning letters. Source: International Pharmaceutical Regulatory Monitor
Indian Court Orders Pfizer to Dump Soon-to-Expire Quantities of Medrol
An Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Source: International Pharmaceutical Regulatory Monitor
Study: Drug Retail Prices Highest in U.S., Least Affordable in India and China
While retail prices for cancer drugs may be the highest in the U.S., these medicines appear to be less affordable in poorer countries such as India and China despite their…
AMR Report Recommends Financial Incentives for Vaccine Development
A new report out of the UK this week recommends monetary incentives to induce drugmakers to develop vaccines for drug-resistant infections. Source: International Pharmaceutical Regulatory Monitor
NICE Gives Soft ‘No’ to Janssen’s Leukemia Treatment, Rejects Roche’s Perjeta
The UK’s National Institute for Health and Care Excellence refused to recommend Janssen’s chronic lymphocytic leukemia treatment Imbruvica for reimbursement in June, but left the door open to further discussion.…
Report: EMA Approval Recommendations Rose in 2015, Cancer Drugs Doubled
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. Source: International Pharmaceutical Regulatory Monitor
France to Tighten Clinical Trial Regulations Following Fatal Trial, EMA to Conduct Review
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Source: International Pharmaceutical Regulatory Monitor
EU Seeks Harmonization of U.S. and European Rules on Approval, Guidelines and GMP
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Source: International Pharmaceutical Regulatory…
Two India Drugmakers Chided by Italian Authorities for GMP Issues
Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues. Source: International Pharmaceutical Regulatory Monitor
Croatian Regulator Slams Indian API Maker for 32 Alleged GMP Violations
Indian API maker Dhanuka Laboratories could lose its EU GMP certificate after an inspection turned up 32 violations. Source: International Pharmaceutical Regulatory Monitor