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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
September 17, 2021
Pfizer has expanded its voluntary recall to include all lots of varenicline (Chantix), but FDA allows continued distribution of the drug product to continue due to drug shortages.
Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.
FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.
Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.
Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.
September 16, 2021
FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.
Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.
EFSA’s evaluation of risk in food products raises implications for drug product formulations.
Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.
September 15, 2021
A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.