FDA's ANDA activity
Executive Summary
Generic Drugs Division ANDA "actions," including approvals, increased from 2,149 in 1984 to 5,379 in 1985 to 7,430 in 1986, according to agency data distributed at a Nov. 3-4 Pharmaceutical Manufacturers Association meeting. Actual ANDA approvals during the same three years increased from 382 to 389 to 616. Original ANDAs filed with FDA jumped from 470 in 1984 (when the post-1962 ANDA/patent extension law was enacted) to 1,069 in 1985 and 1,062 in 1986; 814 of the ANDA filed in 1986 have been for post-1962 products. Post-1962 approvals have been granted to 14 brandname and 41 generic drug manufacturers since the law was passed. Eight of the generic firms received first-ever post-1962 ANDAs.
You may also be interested in...
Prop 65 Warnings Intended For Small Spaces But Used On Luggage? California Proposes Limits
California proposes limiting short-form Prop 65 warnings to products with 5 inches or less of labeling space, while prohibiting their use in online and catalog warnings. The number of products with the warnings, used even on vacuum cleaners, luggage and guitars, has made tracking them impossible.
EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: