Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

FDA 52

FDA Food and Drug Administration Physicians Safety 52

European Pharmaceutical Review

JUNE 8, 2023

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. References Smoking, Drinking and Drug Use among Young People in England, 2021. The harmful effects of smoking are well known, causing more avoidable deaths than any other single cause.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

Pharmaceutical Technology

JULY 10, 2008

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%,

Food and Drug Administration 52

Food and Drug Administration Medicine Pharmaceutical Government 52

Pharmaceutical Technology

MAY 3, 2023

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.”

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Competition 98