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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
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
The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance. Read More
A federal appeals court has ruled that companies participating in the 340B drug pricing program may restrict discounts to hospitals that use multiple contract pharmacies, handing appellants Sanofi, Novo Nordisk and AstraZeneca a major win in their ongoing fight with HHS. Read More
Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response based on insulin-like growth factor 1 (IGF-1) levels in early-phase trials, the FDA said in a draft guidance released Monday.
The FDA’s Center for Biologics Evaluation and Research (CBER) has released its guidance agenda for 2023, including five planned guidances on tissues and advanced therapies.