Quality Systems

Complying with Compendial Requirements

September 28, 2023

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval

September 26, 2023

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

Sucralfate Oral Suspension Recalled Due to Microbial Contamination

September 25, 2023

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.

The European Commission Approves Severe Alopecia Areata Treatment

September 21, 2023

Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.

EC Approves Fixed-Dose Oral Combination Treatment for AML

September 20, 2023

Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.

Staying Compliant in 2023

September 20, 2023

Leaders at CDER and CBER give update on organizational changes at FDA.

EMA Prepares for Regulation on Health Technology Assessment

September 19, 2023

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

FDA Approves Treatment for Myelofibrosis Patients with Anemia

September 19, 2023

Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.

Being Innovative in CGMP Training While Adapting to Change

September 19, 2023

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment

September 19, 2023

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.