FDA NEW DRUG REVIEW CARCINOGENICITY ASSESSMENTS will be referred routinely to a new internal advisory group within the agency, the Carcinogenicity Assessment Committee (CAC). The committee was formed at the beginning of this year to aid the Center for Drug Evaluation's scientific review divisions in assuring consistency in evaluations of cancer studies. In addition to standardly advising on the carcinogenicity studies portion of new drug applications, the committee will examine other carcinogenicity issues as requested by the agency. The committee reviews carcinogenicity study results, design and execution, then issues an advisory opinion to the appropriate review group within FDA. The group is chaired by Judi Weissinger, PhD, assistant director for pharmacology/toxicology, Office of Drug Evaluation II. The regular members of the panel include the supervisory pharmacologists of the new drug review divisions and the head of the statistical animal review branch. The statistical and pharmacology/toxicology reviewers on the drug being evaluated become temporary members. The committee will also call in special advisors on an ad hoc basis, including office directors and deputy directors, veterinary pathologists from the National Toxicology Program, and members of a counterpart carcinogenicity assessment group already in existence at FDA's Center for Food Safety and Applied Nutrition. One near-term project for the CAC is the ongoing debate on the carcinogenic potential of the popular anti-acne drug benzoyl peroxide ("The Pink Sheet" July 2, p. 9), at the request of the Office of OTC Drug Evaluation.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.
Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.
