Fierce Pharma

Forma Life Sciences launches with oral solid dose focus, joining class of new CDMOs

Forma Life Sciences, which inherited BioDuro’s California production operations earlier this year, has officially ...
JD Supra

A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs

Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while ...
JD Supra

FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product specific guidances to align with ICH M13A BE ...

The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...
Hosted on MSN

Two Pharma Companies Partner to Open Dedicated OSD Form Suite in Sellersville

Piramal Pharma Solutions and NewAmsterdam Pharma Company will be opening a dedicated oral solid dosage form suite at Piramal’s facility in Sellersville. The Sellersville site is one of Piramal Pharma ...