FDA Singles Out Three Drug Substances to Not be Compounded

USA – FDA Singles Out Three Drug Substances to Not be Compounded

The US Food and Drug Administration (FDA) on Monday identified three bulk drug substances that it is proposing to not include in a list...
Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages

Asia – Six Asian Firms Blocked for Refusing FDA Inspections

Four Chinese, one Indian and one South Korea-based drug manufacturer have been added to the US Food and Drug Administration’s (FDA) import alert list...
FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

USA – FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions

A recent US Food and Drug Administration (FDA) draft guidance on a requirement under the Risk Evaluation and Mitigation Strategy (REMS) program for pharmaceutical...
Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

USA – Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on...

Companies took issue with specific elements of the draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure. Roche/Genentech explained,...
510(k) Modernization: FDA Floats Need to Pursue New Authority

USA – Drug Prices in Ads: Senate Passes Amendment

The Senate spending bill passed Thursday and with it an amendment from Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) to require prescription drug...
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

USA – FDA Recommends Use of Placebo Only in Certain Oncology Trials

Given the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease, the US...
Researchers Question Level of Patient Input in Clinical Outcome Assessments in FDA Compendium

USA – Researchers Question Level of Patient Input in Clinical Outcome Assessments in FDA...

A team of researchers from the University of Maryland School of Pharmacy say they were unable to find information about the development or validation...
Esmya: new measures to minimise risk of rare but serious liver injury

Europe – Esmya: new measures to minimise risk of rare but serious liver injury

EMA concludes review of medicine for uterine fibroids On 31 May 2018, the European Medicines Agency (EMA) recommended that several measures be put in place...
ICH M9 on biopharmaceutics classification system based biowaivers

Europe – ICH M9 on biopharmaceutics classification system based biowaivers – Step 2b –...

Summary This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III...
EMA Suspends Publication of Clinical Trial Data

Europe – Brexit Impact: EMA Suspends Publication of Clinical Trial Data

As of 1 August, the European Medicines Agency (EMA) has suspended all new activities related to the publication of clinical data. EMA said it will continue to...

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