Quality Systems

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.

PerkinElmer has unveiled a cell analysis solution to streamline cell and gene therapy research and manufacturing.

FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.

EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.

Choosing low-adsorption glass vials helps ensure detection accuracy.

Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.