All members of a joint advisory panel noted an urgent need to expand naloxone access and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also raised concerns about the testing needed for the DFl Facts label the firm unveiled during the meeting.
The US Food and Drug Administration has six weeks to decide whether to follow an advisory committee's unanimous recommendation to approve the first OTC switch proposal for a naloxone product or to ask the sponsor to test labeling first revealed during the meeting.
The agency will weigh approving Emergent BioSolutions, Inc.’s supplemental new drug application for OTC sale of its Narcan (naloxone/4...
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.
US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.
The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
