Retailers Anxiously Await DEA Guidelines On Meth Act, PSE Logbooks
• By Regina Lapierre
Chain drug stores are growing increasingly worried about their ability to implement provisions of the Combat Meth Act before the Sept. 30 deadline as the Drug Enforcement Administration continues to delay issuing its new requirements for sale of pseudoephedrine products, according to NACDS VP-Pharmacy Regulatory Affairs Kevin Nicholson
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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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The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.