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Market Access

As FDA inspections return, upholding compliance and maintain...

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business.

Patients

Engaging change: Connecting patients and regulators can move...

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making.

News

FDA backs pharmacist prescribing of Paxlovid for COVID

Some patients with COVID-19 will be able to get easier access to Pfizer's oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug.

Market Access

Are timely access and robust safety mutually exclusive?

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety?

News

Eisai/Biogen could get FDA verdict on new Alzheimer's drug b...

The FDA has started an accelerated review of Eisai and Biogen's a new amyloid-targeting antibody lecanemab for Alzheimer's disease, with a 6 January deadline that keep them ahead of closest

News

FDA rejection of Spero's tebipenem 'raises resistance threat...

The FDA's decision not to approve Spero Therapeutics' oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic re

As FDA inspections return, upholding compliance and maintain...

Engaging change: Connecting patients and regulators can move...

FDA backs pharmacist prescribing of Paxlovid for COVID

Are timely access and robust safety mutually exclusive?

Eisai/Biogen could get FDA verdict on new Alzheimer's drug b...

FDA rejection of Spero's tebipenem 'raises resistance threat...

ASH: AstraZeneca's dual-wielding CAR-T shows promise

How to meet your physicians where they are online

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