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August 03, 2020
As biopharma companies and research institutes work to develop vaccines against COVID-19, policy makers and health officials debate strategies for ensuring fair and equitable distribution of anticipated preventives.
Regulatory, analytical, and process concerns must be taken into account.
August 02, 2020
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.
Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.
EU regulators are requesting more effective action be taken to tackle serious impurities in APIs and finished products.
When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.
August 01, 2020
Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.
July 30, 2020
EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.
EMA's CHMP has adopted a positive opinion for Dapivirine Vaginal Ring for women in non-EU countries where HIV disease burden is high.