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Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture but measuring the maturity of that culture takes more than just looking at metrics, according to several experts speaking at a recent FDAnews webinar. Read More
Lyne Laboratories’ Brockton, Mass., drug manufacturing facility was handed a seven-observation Form 483 for inadequate investigations of complaints, lax batch records and other deficiencies. Read More
In this special report, Drug Industry Daily examines how the drug supply chain has evolved during the pandemic. Part 1 focuses on the special challenges to manufacturers of generics.Read More
The FDA has asked for feedback on an International Council for Harmonization (ICH) draft guideline on bioequivalence (BE) studies for immediate-release solid oral drugs. Read More
In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that would make research data shareable among sponsors, clinical trial sites and regulators. Read More