FDA SHOULD ALLOW POST-MARKETING SURVEY DATA IN LABELING, LILLY PREGNANCY GROUP SAYS; LILLY HAS PREGNANCY REGISTRIES FOR FOUR PRODUCTS, INCLUDING PROZAC
Executive Summary
Post-marketing surveillance data should be used as a source for expanded pregnancy labeling, Lilly clinical trial psychiatrist Freda Lewis-Hall, MD, suggested at FDA's Sept. 12 public hearing on pregnancy labeling.
You may also be interested in...
Pfizer's Lewis-Hall To Represent Pharma Interests On PCORI Board
Freda Lewis-Hall was among nominations from both BIO and PhRMA to sit on governing board of new comparative effectiveness entity created under the health care reform law.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011