FDA Contracts For QRA Model To Determine Safe Use Levels For 26 Fragrance Allergens

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

Bayer's Iberogast Advance's combination of six herbal ingredients may produce a synergistic effect that acts on multiple underlying issues contributing to digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS), a recently published study suggests.

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.