Pathways & Standards

CBER will strive to respond to post-meeting clarification requests within three business days rather than the usual 20 calendar days, according to an updated policy reflecting the expansion of a pilot program that began in the drugs center.

The CDER Office of Generic Drugs published a MaPP for prescription-to-nonprescription switches to explain the regulatory responsibilities of generic sponsors.

Experts said the impact of the planned approval standard changes are difficult to assess given the potential for flexibility outlined in the JAMA article, as the FDA again eschews guidance and public comment in making new policy.

After voting to change the recommendation for a hepatitis B vaccine birth dose, the CDC Advisory Committee On Immunization Practices laid the groundwork for for changes to adjuvant policy.

The FDA previously rejected AstraZeneca’s bid to convert the Factor Xa inhibitor reversal agent from accelerated to regular approval amid concerns about adverse events and the clinical meaningfulness of benefits seen in the confirmatory trial.

A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.

Flagship Pioneering is first partner in initiative aimed at giving drug developers early, informal, joint advice to fast-track the ‘most promising’ health care innovations. Pathway builds on an artificial intelligence collaboration between the UK MHRA and Singapore’s Health Sciences Authority.

Industry representatives raised several concerns about an FDA proposal to charge additional fees to sponsors not conducting Phase I trials in the US, including that the idea could increase the burden of drug development overall.

A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.

Industry representatives raised several concerns about an FDA proposal to charge additional fees to sponsors not conducting Phase I trials in the US, including that the idea could increase the burden of drug development overall.

The agency wants to ensure orphan drug sponsors cannot benefit from fee exemptions while gaining approval of non-orphan indications.

Non-malignant hematology, respiratory and cardiometabolic candidates make up for an unusual lack of oncology products on the US FDA’s December user fee goal calendar.