Adverse Reaction "Overview" Section Would Reduce Clarity - PhRMA Says
Executive Summary
FDA's proposed "Overview" section for adverse reaction labeling would make labeling more confusing for prescribers, the Pharmaceutical Research & Manufacturers of America said in comments on the agency's draft guidance.
You may also be interested in...
Product Labeling Should Add "Expected" Adverse Event Section, Bristol Says
Bristol-Myers Squibb is proposing the addition of an "expected" adverse events section to product labeling in order to minimize regulatory reporting of events that occur frequently in both drug and control groups, the company said in comments on FDA's AE labeling draft guidance.
Product Labeling Should Add "Expected" Adverse Event Section, Bristol Says
Bristol-Myers Squibb is proposing the addition of an "expected" adverse events section to product labeling in order to minimize regulatory reporting of events that occur frequently in both drug and control groups, the company said in comments on FDA's AE labeling draft guidance.
FDA Adverse Event Draft Guidance Would Restrict "Well Tolerated" Claims
FDA would restrict the use of nonspecific safety claims such as "well tolerated" under its draft guidance on adverse event labeling.