USA – FDA issues draft guidance to enhance efficiency in drug development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minimal residual disease (MRD)'s potential as a surrogate endpoint in clinical trials when he unveiled FDA's draft guidance on using MRD...
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...
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...
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...
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The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development...
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...
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...
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...
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...
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The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance designed to allow for FDA to reject 505(q) petitions if the...
