This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.

Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

As the European Commission prepares to publish its proposals for overhauling the EU pharmaceutical legislation at the end of the year, member states have been discussing a range of technical and legal issues such as the scope of the centralized approval procedure, the use of electronic product information and the shortage of inspection capacities.

A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.

In the report accompanying FY 2023 HHS appropriations legislation, the House committee also addresses biosimilar uptake in Part D, Medicare dispensing fees for oral COVID-19 drugs and NIH grants for expanded access to investigational ALS drugs.

England’s health technology appraisal institute, NICE, has published its real-world evidence framework.

The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.

Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.

Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

News and views from day four of the BIO annual meeting include a fireside chat with FDA commissioner Robert Califf, gene therapy insights, and pharma efforts to provide cancer medicines in lower income countries.

Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?

If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.

Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.