Quality/GMPs

FDA struggles to track shortages caused by a rise in demand.

The complete online database of ACS Reagent Chemicals is now available.

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.

Health crises, political tension, and budget concerns were major challenges.

Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

New medications show exciting outcomes for weight loss.

Industry experts discuss best practices for certificates of analysis.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA keeps its user fees but fails to gain important reforms.

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.