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May 10, 2021
The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.
May 07, 2021
Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.
May 06, 2021
FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.
Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.
May 02, 2021
Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
April 21, 2021
A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.
April 14, 2021
This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.
April 09, 2021
Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.