Sanofi's Opella: FDA Lifts Clinical Hold On OTC Cialis Trial
Sanofi's Consumer Healthcare division, Opella, announced that the U.S. Food and Drug Administration has lifted a clinical hold on its ...
JD Supra3d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
New FDA rule to boost OTC drug access, but self-screening required
Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).
Petros announces ‘conducive position’ with newly approved FDA OTC final rules
Petros Pharmaceuticals (PTPI) announces its conducive position in connection with the recently issued final rule, “Nonprescription Drug ...
pulmonologyadvisor5d
Over-the-Counter HIV Test Approved for Adolescents
The Food and Drug Administration has approved the OraQuick® HIV Self-Test to include individuals 14 years of age and older.