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Trump's second term is bringing back some concerns from his first term, adding pressure to the health sector. Tariff threats, drug pricing will be 2 key pharma issues during Trump's first year [Video]
The Drug Industry Documents Archive (DIDA) is a digital archive of pharmaceutical industry documents created and maintained by the University of California, San Francisco, Library and Center for Knowledge Management. DIDA is a part of the larger UCSF Industry Documents Library which includes the Truth Tobacco Industry Documents.
"I'm gonna create borders," Donald Trump promised during his 2016 campaign. "No drugs are coming in. We're gonna build a wall. You know what I'm talking about. You have confidence in me.
The FDA argued that it needed additional staff to end its back-log of drugs awaiting approval for market. The FDA had not received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical industry generally opposed them, fearing that the funds would not be ...
The small amounts of fentanyl in any shipment — the drug is 50 times more potent than heroin — and its lack of odor, make detection and seizures extremely challenging. Fentanyl is also made in Canada and smuggled into the U.S., but to a much lesser extent.
Trump, who takes office on Jan. 20, 2025, said he would impose a 25% tariff on imports from Canada and Mexico until they clamped down on drugs, particularly fentanyl, and migrants crossing the ...
Drug innovators were given protections in two ways. First, a new kind of market exclusivity was introduced, by means of a new five-year period of data exclusivity awarded when the FDA approves marketing of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug. [3]
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.