Susan Haigney

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

Bettersize US showcases their BeNano Series, Bettersizer 2600, and BetterPyc 380 instruments at the AAPS 2023 PharmSci 360 event.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

The program will improve access to adeno-associated virus gene therapy vectors.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

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

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

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public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

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

Environmental monitoring data can help keep sterile environments sterile.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Data from environmental monitoring can assist in keeping sterile environments sterile.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

The agency has published guidance on good practices for securing the supply of medicines.