New Report Compares FDA Quality System Requirements With ISO 13485:2016

USA – FDA offers insight into product quality assessment principles

The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications...

USA – European, US guidance differs on API nitrosamines

HARDLY A DAY goes by without mention of a newly emerging active pharmaceutical ingredient (API) nitrosamine, eg, nitrosamine propranolol.1 This has led to a great...

USA – FDA starts PDUFA VII programs for real-world evidence, innovative trial designs

The US Food and Drug Administration (FDA) on Tuesday provided updates on two programs negotiated under the Prescription Drug User Fee Act (PDUFA VII)...

USA – Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH

Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international...
FDA: 2019 Continues Uptick in Orphan Drug Approvals

USA – Study: One-fifth of recent FDA approved drugs not authorized, reimbursed in other...

More than one-fifth of drugs recently approved by the US Food and Drug Administration (FDA) were not approved or recommended for public reimbursement in...

USA – Global regulators discuss how they are adapting to AI, real-world data in...

Regulators across the globe have been preparing for the arrival of new artificial intelligence (AI) technologies and advances in real-world data (RWD) they say...

USA – FDA establishes advisory committee for genetic metabolic disease treatments

The Genetic Metabolic Diseases Advisory Committee will advise the FDA on products used for the diagnosis, prevention and treatment of genetic metabolic diseases under...

USA – FDA officials reflect on quality maturity model, quality metrics

The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said...

USA – FDA finalizes guidance on submitting RWD/RWE in application cover letters

To help better track submissions that include real-world data (RWD) and real-world evidence (RWE), the US Food and Drug Administration (FDA) is asking drug...

USA – FDA drafts guidance on ‘sameness’ evaluations for generic drugs

The US Food and Drug Administration (FDA) has released new draft guidance offering recommendations for applicants to prove sameness in active ingredients of abbreviated...

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