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FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency describes the current system as “confusing, conflicting, incomplete, or repetitive”, based on study data.

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FDA AdCom votes unanimously in favour of OTC oral contraceptive

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA approved Opill for prescription use in 1973. The therapy only contains the hormone progestin and is taken once daily.

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Illegal online pharmacies gain traction as regulators lag behind

Pharmaceutical Technology

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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OTC Narcan will cost ‘less than $50’, company says

Pharmaceutical Technology

Whilst Emergent has broken through to produce a drug that reduces opioid mortality rates , experts say the company’s pricing strategy might put it out of reach for those who need it most. On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription.

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FDA AdCom votes in favour of first gene transfer therapy for DMD

Pharmaceutical Technology

In a closely contested debate, a US Food and Drug Administration Advisory Committee (AdCom) panel voted eight to six in favour of the accelerated approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene transfer therapy delandistrogene moxeparvovec (SRP-9001).

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Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

Pharmaceutical Technology

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased.