OR WAIT null SECS
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.
January 26, 2022
Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.
January 21, 2022
The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.
AstraZeneca's Tagrisso has been accepted for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations in Scotland.
January 19, 2022
The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination.
The agency discusses its response to COVID-19 and other milestones in its year-end review.
The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.
January 14, 2022
According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.
The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.
January 12, 2022
The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).
January 10, 2022
FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).