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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Planning and the proper use of technology facilitate effective remote auditing.
Precompetitive efforts demonstrate that collaboration is essential to serve patients.
May 01, 2021
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.
April 21, 2021
The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.
Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.
April 20, 2021
FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.
April 19, 2021
The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.
April 15, 2021
This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.
April 14, 2021
Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.
April 13, 2021
CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.
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.
April 01, 2021
The adoption of single-use technologies in fluid-handling systems helps streamline downstream bioprocessing operations.