PHARMACIA NICOTINE NASAL SPRAY REQUIRES DISTRIBUTION RECORDS be kept to help prevent abuse of the smoking cessation product if it is approved for marketing, FDA's Drug Abuse Advisory Committee recommended Aug. 1. The committee also recommended a limit be imposed on the number of refill prescriptions patients could obtain without reassessment by the prescriber. The panel recommended against requiring triplicate prescriptions or secured storage areas for the product. Pharmacia's NDA for the nicotine nasal spray as an aid to smoking cessation was filed in July 1993.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
