The FDA issued two final guidances about preventive and pediatric HIV treatments. The guidance on developing systemic drug products for pre-exposure HIV prophylaxis addresses the overall development program and clinical trial designs. It provides nonclinical and clinical recommendations, with a focus on long-acting systemic drugs, including small molecules and monoclonal antibodies. The second guidance gives general recommendations on the development of antiretroviral drugs for pediatric patients. It also addresses when to initiate pediatric studies and offers approaches for enrolling participants to help facilitate drug development. Both guidances were issued as drafts last year.

The U.S. Agency for Healthcare Research and Quality's Evidence-based Practice Centers Program is looking for help in identifying completed or ongoing studies of various treatments for chronic pain. The studies will be used to inform three separate comparative-effectiveness reviews. One will focus on opioid treatment, with the other two reviewing noninvasive nonpharmacologic treatments and non-opioid pharmacologic treatments. All three reviews will look at effectiveness following short-term treatment (three to six months), intermediate-term treatment (six to 12 months) and long-term treatment (more than a year).

An FDA reorganization proposed last year to strengthen how the agency fulfills its public health and regulatory role has been approved. The organizational changes will take effect March 31. The changes at the Center for Drug Evaluation and Research (CDER) include a new Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs (OND). The increasing complexities and visibility of CDER's biologic program necessitated "a dedicated office to efficiently and effectively achieve cross-organizational coordination and collaboration – and advance policy development for these products," center Director Janet Woodcock said. Also the OND's Office of Hematology and Oncology Products will establish a third oncology division, a second hematology division, a division of regulatory affairs, and centralized safety reporting and labeling teams.