Quality Systems

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.

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

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

FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

What implications will EMA’s recent regulatory reform have on pharma?

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

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

An increase in applications for gene therapies is putting stress on FDA’s resources.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.