Regulatory Affairs

Apotex Sues Health Canada Over Import Ban

Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More

FDA Beefing Up Inspections Presence in China

The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More

EMA Panel Recommends Drugs for Hep C, Gaucher Disease

An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More

UK Kicks Off Review to Speed Drugs to Market

The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More

Senate Subcommittee Probes Price Increases for Certain Generics

The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation yesterday that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More