Quality Systems

Judith M. Sills, PharmD, is a nonexecutive director and advisor to Arriello—a provider of risk management and compliance services to the Life Sciences industry.

Eric Caugant is a nonexecutive director and advisor to Arriello—a provider of risk management and compliance services to the Life Sciences industry.

Articles

International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.

Navigating International Pharmacovigilance

Agnes Shanley is senior editor of Pharmaceutical Technology.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk. 

Prioritizing  Cleaning Validation

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Moderna Initiates Rolling Submission of Biologics License Application for its COVID-19 Vaccine

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

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

Pandemic Highlights Need for Advanced Pharma Manufacturing

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

The Facts About Filing Drug Applications

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19. 

FDA Issues EUA for mAb Therapy for the Treatment of COVID-19

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally. 

Vaccine Makers Ramp Up Production, Donations to Protect IP

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

Further Advice on Vaxzevria Issued in Europe

EMA has recommended EU marketing authorization for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC).

EMA Recommends EU Marketing Authorization for Bylvay

CMA has launched an anti-competition investigation into AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals. 

Regulatory Oversight and Compliance