FDA Oral Contraceptives Labeling Guidance Removes Mention Of Emergency Use
This article was originally published in The Pink Sheet Daily
Executive Summary
First draft of guidance listed dosing regimens appropriate for emergency use; PhRMA questioned inclusion of the information in earlier comments.
You may also be interested in...
FDA Oral Contraceptives Guidance "Oversimplifies" Risk Information, J&J Says
Johnson & Johnson is concerned that the draft guidance will not "objectively relate the risks" to physicians. The company also recommends including newer references for risk information.
US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: