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May 02, 2021
Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
April 29, 2021
The UK’s Medicines and Healthcare products Regulatory Agency has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.
The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.
ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.
April 26, 2021
The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.
April 23, 2021
EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.
April 21, 2021
A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.
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.