CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission. Read More

An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products. Read More

The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More

The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More

To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first. Read More