Approval Standards
A US FDA Advisory Committee responded enthusiastically to the potential use of challenge models to enable pivotal trials of novel pertussis vaccines, but most members suggested more refinements are needed before they are ready to use.
The FDA’s vaccine advisory committee endorsed a new plan to update pandemic influenza vaccines “inter-pandemic,” but encouraged the agency to consider how to make the approach feasible for novel vaccine technologies.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The program for collaborative gene therapy reviews with the European Medicines Agency is starting with simple applications, but after launch could be expanded to earlier discussions of CMC and pharm/tox data requirements, the FDA’s Nicole Verdun said.
As need for new antibiotics keeps increasing, a recent US FDA advisory panel offers a case study of why industry isn’t keen on the space.
The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.
The European Medicines Agency has highlighted issues for drug developers to consider when seeking to submit clinical data from SATs as the pivotal evidence in their marketing authorization applications instead of randomized controlled trial data.
Studies should enroll a representative subgroup of US patients based on the incidence or prevalence of cancer in the US, and the comparator arm should use the US standard of care when possible, the FDA says in draft guidance.
The European Commission has registered a European citizens' initiative that explains how the EU can foster equitable, timely, affordable, safe and legal access to innovative psychedelic-assisted treatments. Work towards securing the one million signatures needed for the next step is starting soon.
Disputes over orphan and new clinical investigation exclusivity are among the early drug and biologic cases where legal filings cite the Loper Bright decision, which overturned the Chevron doctrine of deference to agency actions.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Even as US FDA expressed concern about the perioperative trial design, AstraZeneca’s ability to snag NSCLC indication without demonstrating the benefits of both the neoadjuvant and adjuvant phases of therapy highlights slow pace of agency policy shifts.
The agency’s final guidance retains a draft recommendation for a randomized, parallel dose-response trial when comparing multiple dosages, but is more forceful in wanting sponsors to talk to the FDA early if they want advice tailored to their development programs.
AstraZeneca’s Imfinzi lung cancer advisory panel, which offered insight into why sponsors do not always follow agency advice, likely is a preview of the hurdle facing Bristol Myers Squibb’s Opdivo application for the same indication.
The Oncologic Drugs Advisory Committee urged the FDA not to delay Imfiniz’s perioperative NSCLC indication, while also unanimously pushing for better trial designs in lung cancer and all resectable tumors.
The FDA’s experience with product-specific guidances for generic drugs may impact biosimilar industry decision-making, but the program has improved in recent years.
Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.
The Oncologic Drugs Advisory Committee will vote on a product agnostic question related to perioperative trial designs during a 25 July meeting after discussing whether AstraZeneca needs an additional trial for its Imfinzi perioperative regimen in non-small cell lung cancer.
Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.