FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.
FDA has released Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment, Draft Guidance to assist sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP). The guidance addresses development program and clinical trial designs for drugs to support an indication for the treatment of CABP and is intended to serve as a focus for continued comments and discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.
This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidance for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.
This guidance revises a 2009 guidance, Pneumonia: Developing Drugs for Treatment.
Source: FDA.gov
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.