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FDA Approvals

FDA Under Strain To Amend The Accelerated Approval Program

FDA Approvals
The necessity to update and alter the FDA's now-contentious rapid approval strategy is highlighted by the protracted, complicated FDA process to discontinue commercialization of...

CDC Recommends Novavax COVID Jab To Mix With Pfizer, Moderna

FDA Approvals
The Centers for Disease Control and Prevention on October 19 advised adults in the United States to take Covid boosters from Novavax, even those who...

Rare Illness Study Will Get $38mn FDA Funding Over 4 Years

FDA Approvals
A total of $38 million has been granted by the US Food and Drug Administration (FDA) in the form of 19 new grants and...

FDA Explores For Ways That Help Tailored Gene Treatment

FDA Approvals
Peter Marks, a top official at the Food and Drug Administration, is not tasked with determining if the expense of the medicines his teams...

FDA Okays Pfizer, Moderna Omicron Boosters For Kids

FDA Approvals
Following a decision by the Food and Drug Administration to broaden its authorization of reformulated shots from Moderna and partners Pfizer and BioNTech, kids...

The User Fees At The FDA Have Been Authorized Once Again

FDA Approvals
As anticipated, four important user fee programmes were renewed by Congress for the week ending October 1st as part of a bill that was...

The FDA Increases Patient Input During Drug Development

FDA Approvals
The FDA started a programme ten years ago to increase the role of patients in educating sponsors and regulators on the most detrimental impacts...

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White Papers

The Future of Digital Health

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The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

Five Best Practices to Deliver Exceptional Multichannel Experiences

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A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

The Impact and Use of Social Media in Pharmacovigilance

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Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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