Quality Systems

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The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

FDA Approves Biosimilar for Treatment of Eye Disease

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

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

Next Big COVID Challenge: Vaccines for Little Kids

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Vaccine Booster Battle Reveals Rifts Among Regulators and Sponsors

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

Health Canada Approves Moderna’s COVID-19 Vaccine, Spikevax, for 12 Years & Up

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

FDA Revises EUA for Use of Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis Prevention for COVID-19

Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.

Takeda’s Exkivity Approved by FDA

Symbiosis Pharmaceutical Services has successfully completed an on-site inspection, performed by the MHRA, of its expanded facility in Stirling, UK.

Symbiosis Successfully Completes MHRA Inspection of Expanded Manufacturing Facility

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

FDA and EMA Launch Program to Advise Prospective MAAs and ANDAs Applicants

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.

Understanding Combination Product Regulations

EFSA’s evaluation of risk in food products raises implications for drug product formulations. 

Regulatory Oversight and Compliance