FDA-ordered studies of many drugs, devices on the market are not done - The Washington Post

• The FDA has allowed companies to sell drugs and devices while completing safety and efficacy studies, but many of these postmarket requirements are now overdue or behind schedule. • FDA leaders announced in February that the default requirement for agency approvals will shift to one clinical trial instead of two.

• Philadelphia health officials reported a potential measles exposure at the Children's Hospital of Philadelphia on September 11. • The exposure occurred in the neonatal intensive care unit and other locations at the hospital's 3401 Civic Center Blvd facility.

• Lawmakers and advocates are calling on the Trump administration to release over $1 billion in congressionally approved global health funding. • An analysis by Partners in Health shows the Office of Management and Budget is withholding $1.35 billion in bilateral funds.

• An analysis of FDA data revealed that hundreds of required postmarket studies for drugs and medical devices are running behind schedule. • The findings indicate that many manufacturers have failed to complete follow-up research mandated by the agency years after product approval.

• The U.S. Food and Drug Administration approved this season's COVID vaccines nearly three weeks ago for general use. • Children with private insurance can currently access the shots, but those in the Vaccines for Children program must wait for Health and Human Services sign-off.

• South Korea is expanding its research and development support program from five to all nine regional national university hospitals, with a second phase beginning in 2028. • The program funds advanced medical research including genomic big data analysis and whole-exome sequencing, which identifies mutations across all protein-coding regions of the genome.

• Montana is granting the biotech industry broad authority to sell unapproved drugs, allowing patients to access experimental treatments regardless of federal regulations. • The state's move bypasses the standard FDA process, which typically requires three phases of clinical trials to assess efficacy, dosage, and adverse events.

• The FDA continues to face operational challenges and hiring freezes resulting from budget cuts implemented by the Department of Government Efficiency (DOGE). • These cuts have stymied the agency's ability to fill critical roles and maintain standard staffing levels.

• Sarah Axelrath of the Colorado Coalition for the Homeless told the Denver City Council on Monday that targeting drug traffickers does not stop substance use. • Axelrath, an addiction medicine specialist, stated that these law enforcement actions disrupt an already potent and unpredictable drug supply.

• Two new polls indicate a decline in global and U.S. trust regarding medical advice and the safety of the measles vaccine for children. • Only 19% of 1,143 adult respondents approved of President Donald Trump's handling of measles outbreaks, while 52% expressed disapproval.

• The pituitary cancer market is projected to expand at a compound annual growth rate of 9.4% between 2026 and 2033. • DataM Intelligence 4 Market Research LLP reports that the sector is shifting from a specialized oncology niche toward precision diagnosis and targeted treatments.