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.
June 21, 2017
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
June 19, 2017
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
June 16, 2017
The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.
The company recalled a variety of products due to the potential of microbial contamination.
June 15, 2017
Congressional measures lack the support to move forward.
A consent decree of permanent injunction was entered between the United States and the two companies due to unapproved, mislabeled, and adulterated drugs.
The company has extended its voluntarily recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.
June 14, 2017
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.