Quality Systems

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

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

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

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.

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

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

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

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

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

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

Automation can be balanced with operator oversight.

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

Problems continue despite actions by regulators to better prevent and address drug shortages.

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

The debate surrounding drug pricing changes rages on.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.