We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
By the end of next year the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
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
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
Europe’s drug regulatory agency has revised the conflict of interest policy for its scientific committee members and experts, a move that one attorney says recognizes the reality that most knowledgeable specialists have at least some commercial involvement. Read More
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
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
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
Australia and New Zealand have abandoned plans for a joint drug regulatory agency, although both countries say they will continue to cooperate on regulations that are mutually beneficial. Read More
Mallinckrodt has sued the FDA over its decision last week to revoke the equivalence rating on the company’s generic version of Janssen’s attention deficit hyperactivity disorder drug Concerta. Read More
UK’s healthcare cost watchdog says Novartis must provide significantly more clinical trial data on its hives drug Xolair before the group can recommend the therapy for national coverage. Read More