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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
Fezolinetant, Astellas Pharma’s potential first-in-class treatment for menopausal hot flashes, shouldn’t cost more than $2,600 per year if approved, according to a cost-benefit analysis by the Institute for Clinical and Economic Review (ICER) based on the available trial data. Read More
Until a withdrawal of approval of an ANDA is effective, the ANDA holder must comply with post-approval reporting requirements and payment of any required fees, the agency said. Read More