Quality Systems

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

The report highlights international regulators’ plans for the development and availability of vaccines to prevent and drugs to treat mpox.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, talked about the importance of properly characterizing HCPs in the biomanufacturing process.

Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

Various microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times.

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan.

Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

The use of artificial intelligence and machine learning has the potential to provide some key benefits; however, there are still significant barriers to the implementation of these advanced technologies.

Regulators, EMA and HMA, have published principles and recommendations on the use of LLMs, which are being increasingly used for daily tasks.

This Behind the Headlines news roundup panel discussion discusses news items such as research results from the June Lab at the University of Pennsylvania presented at the Hanson Wade 9th CAR-TCR Summit; winter vaccine recommendations, particularly for respiratory syncytial virus (RSV) and Beyfortus access and deployment; upcoming early October Nobel prize announcement predictions; digital biology analytics, quantitation, alongside point of care (POC) and distributed manufacturing. The panel also talks about the Biosecure Act and manufacturing reshoring; Federal reserve interest rate cuts of a full half a percent (1); and the general investment and financial outlook.

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

Contract organizations offer assistance when managing changes to material suppliers during a product’s lifecycle.

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

Greater collaboration and understanding are needed to ensure the correct grade of excipient is used in drug products.

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.

New technologies improve efficiency and remove operator intervention.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.