Quality Systems

Navigating the Formality Spectrum in ICH Q9(R1)

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

Gaining a Deeper Understanding of Aseptic Needs

Increased knowledge is needed to grasp the regulatory landscape surrounding products that require aseptic processing.

A Four-Phased Approach for Evaluating a Quality Risk Management Activity

Using the four-phased method to assess QRM can ensure continual improvement.

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.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

September 18, 2023

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

FDA Issues Guidance on Biosimilar Labeling

September 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Colorcon Launches New Titanium Dioxide Free Moisture Protection Coating for Pharmaceutical Tablets

September 14, 2023

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.