OTC Drugs
The 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) empowered the Food and Drug Administration (FDA) with enhanced mechanisms for overseeing over-the-counter (OTC) medications like cold remedies and sunscreen. A notable amendment introduced by the CARES Act is aimed at revitalizing and updating the OTC drug review process.
At Talati, we are deeply immersed in this landscape and offer invaluable insights into market dynamics and regulatory shifts. From the very start of the product’s journey to every development phase that follows, we make it our mission to offer steadfast support to our clients as they tackle regulatory requirements.
Our comprehensive services to the OTC drug industry encompass:
- Counseling on OTC drug formulation and claims in compliance with FDA OTC regulations.
- Helping with drug facility registration and listing, Good Manufacturing Practices (GMPs).
- Reviewing substantiation and advising on product claims.
- Helping with product recalls and FDA inspections.
- Responding to Warning Letters and FDA enforcement actions.
- Reviewing product label, website and social media pages for compliance.
- Counseling on Import issues including detention and refusals, Import Alert removal and product reconditioning.