Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

USA – FDA issues draft guidance to enhance efficiency in drug development

FDA Commissioner Scott Gottlieb highlighted minimal residual disease (MRD)'s potential as a surrogate endpoint in clinical trials when he unveiled FDA's draft guidance on using MRD...
Médicaments : quelle(s) réalité(s) ?

USA – Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence

Feature articles over the past weeks have focused on the ability to assess and manage the benefit-risk profile of drugs, rules for updating prescription...
Médicaments : quelle(s) réalité(s) ?

USA – FDA Sets Record for Number of Generic Drug Approvals Again

The US Food and Drug Administration (FDA) has approved and tentatively approved more generic drugs in FY 2018 than any other year prior, the...
FDA urges more trials of drug-coated balloons, stents

USA – FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products

The US Food and Drug Administration (FDA) recently posted a Form 483 sent in July to the nation’s largest drug distributor, McKesson, and questioned...
Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance

USA – Complex Generic Drugs: FDA Offers Two Draft Guidances

The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development...
FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy

USA – FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy

The US Food and Drug Administration (FDA) has approved inotersen (Tegsedi, Akcea Therapeutics and Ionis Pharmaceuticals) for the treatment of polyneuropathy (PN) in adults...
The First FDA-approved Digital Pill - What It Means for Pharma

USA – The First FDA-approved Digital Pill – What It Means for Pharma

In mid-November 2017, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill...
New Flu Drug Cuts Time to Recovery

USA – New Flu Drug Cuts Time to Recovery

An investigational drug is safe and effective for patients with risk factors for influenza complications, results from the phase 3 CAPSTONE 2 study (NCT02949011) suggest. For patients...
FDA seeks ways to promote individualized therapies

USA – Atopic Dermatitis: FDA Finalizes Guidance on Timing of Pediatric Studies

The US Food and Drug Administration (FDA) finalized the 3-page guidance to help sponsors understand FDA’s current thinking about the relevant age groups to...
Citizen Petitions: FDA Revises Guidance to Block Drugmakers From Abusing the System

USA – Citizen Petitions: FDA Revises Guidance to Block Drugmakers From Abusing the System

The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance designed to allow for FDA to reject 505(q) petitions if the...

NOS PROCHAINES FORMATIONS