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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.
March 29, 2017
The mAb is the first approved treatment that targets the progressive form of the disease.
March 28, 2017
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.
March 27, 2017
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
March 24, 2017
The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
March 23, 2017
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
March 22, 2017
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.
March 21, 2017
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.