Regulatory Oversight and Compliance

EMA Endorses Track-and-Trace Recommendations

August 10, 2021

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

Emergent Approved to Export Vaccines in Latest COVID-19 Update

August 09, 2021

Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.

EMA Recommends Including Adverse Reaction Warning to Janssen COVID-19 Vaccine

August 09, 2021

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

EMA’s PRAC Requests Additional Data on Guillain-Barré Syndrome in COVID-19 Vaccine

August 09, 2021

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

FDA Approves New Treatment for Pompe Disease

August 09, 2021

FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.

FDA Issues NIR Guidance

August 09, 2021

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

FDA Issues Warning Letter to Syntec Pharma Corp

August 06, 2021

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

EC Confirms Go-Live Date for Clinical Trials Information System

August 05, 2021

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

BMS Gains European Approval for Opdivo

August 04, 2021

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

CHMP Approves Manufacturing Scale-Up for Spikevax

August 04, 2021

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.