Quality Systems

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

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.

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 approval of Comirnaty and Spikevax for children from six months of age.

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

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.

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

CBER maps modernization plan to handle surge in research and applications.

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.

Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.

FDA backs joint reviews, common research policies, and modern production methods around the world.

One can only learn the secrets of "fight club" by attending its meetings.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.

The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.

FDA has approved Relyrio as a once-to-twice daily treatment for patients with ALS.