Drugs

Bioresearch Monitoring Issue at Lovelace Institute

A 4/7-4/18/2025 FDA Bioresearch Monitoring Program inspection at Lovelace Biomedical Research Institute in Albuquerque, NM, found objectionable conditions in the facility’s role in conducting two nonclinical laboratory studies. A 10/6 Warning Letter says the specific violation was:

failure of the quality assurance unit to review the final study report to ensure that the reported results accurately reflect the raw data of the nonclinical laboratory study.

“Because the testing facility’s quality assurance unit failed to ensure that the reported results in the final study report accurately reflected the raw data of the nonclinical laboratory studies, FDA is concerned about the integrity of the data generated and reported from nonclinical studies conducted at your testing facility,” the letter says. The agency says the institute’s response to the inspection observation was not adequate and did not provide sufficient details.

Lovelace was told to respond with a list of actions it has taken to prevent a similar violation in the future.

Container Closure System Guidance Comments

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s attention to container closure systems in light of the significant technological advances that have emerged in material science and drug delivery systems since the agency’s 1999 guidance on the same topic. In a comment letter on an

Gottlieb Urges FDA Regulatory Pathway for ‘Clinical AI’

Former FDA commissioner Scott Gottlieb is calling on Congress to establish a new regulatory pathway for clinical artificial intelligence models developed and used within hospitals, warning that the absence of consistent federal oversight could undermine patient safety and limit broader commercialization of clinical AI technologies. In an October 8 commentary

FDA Launches Rare Disease Framework Initiative

FDA says it is launching a Rare Disease Framework Initiative “to reimagine the development of drugs and biologics for rare diseases.” In a statement, which includes a link to a new white paper on the initiative, the program will “develop an optimized, fit-for-purpose framework that reflects the realities

CGMP Violations at Silgan Dispensing Systems Unit

A 3/26-4/2 FDA inspection of the Silgan Unicep Packaging drug manufacturing facility in Spokane, WA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/5 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure

Read more

Container Closure System Guidance Comments

Gottlieb Urges FDA Regulatory Pathway for ‘Clinical AI’

FDA Launches Rare Disease Framework Initiative

CGMP Violations at Silgan Dispensing Systems Unit