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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103
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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 131
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A history of blood cancer treatment

pharmaphorum

Thanks to the dedicated efforts of doctors, patients, carers, and healthcare professionals, people diagnosed with blood cancer are now living longer, with a steady stream of more effective treatments entering the market each year. 2001– FDA green lights revolutionary treatments. 2002 – Emergence of CAR-T therapy.

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Innovations & Challenges in Brain Health

PM360

They are difficult to diagnose early in a disease, the regulatory endpoints are often unprecedented and challenging, and many drugs struggle to get into the brain. The downside is that it also keeps most potential drug treatments from reaching the brain. healthcare system over $800 billion annually.

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Reality Bites: Disappointment in the R&D Sector

Pharmaceutical Technology

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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Pathbreakers: The journey of first generics

Pharmaceutical Technology

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US. from 2001 to 2022.”