Regulatory Oversight and Compliance

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA has revised the Emergency Use Authorization for sotrovimab.

EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.

EMA has recommended approval of Spikevax for children aged 6 to 11.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.

FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

USP is developing mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.

MHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.

Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

PETA Science Consortium International e.V. and PETA scientist Jeffrey Brown share goals with new FDA Commissioner Dr. Robert Califf.

FDA has approved Pyrukynd (mitapivat) tablets to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

EC has approved Oxbryta (voxelotor) as a treatment for hemolytic anemia in patients with Sickle Cell Disease (SCD) age 12 years and older.

The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.

FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

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