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Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More
The FDA needs to hold more presubmission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More
The FDA is continuing its push to find ways to curtail opioid abuse, calling for suggestions and recommendations on innovative packaging, storage and disposal systems, technologies or designs that would thwart abusers. Read More
Teva Pharmaceuticals asked U.S. Supreme Court Chief Justice John Roberts to recall and stay a July 2013 appeals court ruling invalidating a patent on Teva’s blockbuster multiple sclerosis drug Copaxone, pending the full court’s final decision on the patent case. Read More
Congress is considering new legislation to require the Drug Enforcement Agency to speed up the process of scheduling a drug as a controlled substance and give drugmakers a firm timeline for agency decisions. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Drugmakers decried the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
Genzyme will resubmit its application for an expanded indication in relapsing multiple sclerosis for Lemtrada during the second quarter, following “constructive” talks with the FDA, the company said Monday. Read More
Two new challenges emerged last week to the controversial drug Zohydro ER, as Vermont became the second state to slap restrictions on the drug and U.S. Attorney General Eric Holder announced he would look into the way the FDA approved the product. Read More