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.
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
The incoming head of the European Commission has taken drug regulating responsibilities away from the EU’s health and consumers department and given them to the government’s enterprise and industry department, a decision that was welcomed by a European pharma trade group but criticized by consumers and some lawmakers. Read More
A large Texas compounder has rejected the FDA’s formal request to recall all of its sterile products after an inspection found 22 contaminated lots, a stance that means the dispute could move to court. Read More
A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
Indian regulators are reminding drug investigators seeking approval for clinical trials that they must submit information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product to existing options. Read More
The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency said. Read More
Astellas Pharma and Medivation won a new indication for their joint cancer therapy Xtandi, allowing the drug to be given to a wider swath of men with metastatic castration-resistant prostate cancer. Read More
A federal judge has denied a motion by Merck to dismiss two lawsuits involving its mumps vaccine, one by whistleblowers alleging the company presented misleading efficacy data on the vaccine, and another by direct purchasers who contend the company created a monopoly on the product. Read More
Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line. Read More
Draft FDA guidance on how drugmakers can use social media and web-based forums threatens to prevent the industry from interacting with customers online for fear that companies will be responsible for continuously monitoring any discussions they participate in, drugmakers say. Read More
The FDA said yesterday that Justice Department official Cynthia Schnedar will become director of CDER’s Office of Compliance starting Oct. 6. Read More