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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 07, 2021
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.
The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.
October 01, 2021
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
September 27, 2021
The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.
September 16, 2021
FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.
August 27, 2021
Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.
August 24, 2021
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
August 23, 2021
Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.