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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may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance.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and/or exposure-response based on insulin-like growth factor 1 (IGF-1) levels in early-phase trials, the FDA said in a draft guidance released Monday.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.
The International Council for Harmonization (ICH) has issued the final version of its revised guideline on quality risk management ICH Q9(R1), adding information on risk management methodology, such as assessing the degree of risk analysis required, risk-based decision-making and managing subjectivity.