Quality Systems

Articles

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

FDA Under Pressure to Restore “Normal” Drug Inspections

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

FDA Approves Merck’s 15-Valent Pneumococcal Vaccine

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

FDA Approves Amneal’s Generic Version of TobraDex

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD. 

EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic. 

Samsung Biologics Partners with Kineta for Anti-VISTA Antibody Immunotherapy

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

Tevogen Bio Partners with Yale in Regulatory Sciences Program Expansion 

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

Regulatory Oversight and Compliance