USA – FDA authorizes second round of mRNA boosters for older and immunocompromised people

The US Food and Drug Administration (FDA) on Tuesday signed off on a second round of COVID-19 vaccine booster shots for immunocompromised individuals and...

USA – Cavazzoni: Pandemic-era tools, learnings are here to stay

The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA issues final rule on ‘right to try’ reporting requirements

Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a...

USA – FDA takes first step to allow low-dose OTC naloxone on market

Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by...

USA – FDA issues draft guidance on dosage and administration labeling

The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section...

USA – Pharma wants FDA’s IND reporting rule better aligned with ICH E2F

Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with...

USA – FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals

The US Food and Drug Administration (FDA) on Wednesday issued draft guidance offering examples of how drug sponsors can rely on generally accepted scientific...

USA – FDA offers guidance on waiver requests for pH adjusters

The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Easier access to locally-applied HRT to treat postmenopausal vaginal symptoms in landmark...

For the first time ever in the UK, postmenopausal women will be able to access a low dose Hormone Replacement Therapy (HRT) product from...

USA – Sentinel System expands capacity, data linkages, report indicates

The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions...

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