FDA Drug Center Guidances To Address OTC Drug Innovation, Drug Competition, Biologic License Provisions, Advertising

FDA's drug center released Friday (Jan. 19) its 2018 guidance agenda, which includes new categories focused on over-the-counter (OTC) drug development and rare diseases. Other guidances will address the biosimilar law’s deemed to be a license provisions; waiving the single, shared Risk Evaluation and Mitigation Strategies (REMS) requirements; developing medication-assisted treatment (MAT); and compounding. Over-the-counter drugs. The plan, published Friday (Jan. 19), includes a new category for OTC drugs. The agency indicates that it will publish guidance on “Innovative Approaches...