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The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance designed to allow for FDA to reject 505(q) petitions if the...
La vaccination contre les papillomavirus étendue aux garçons

USA – FDA Warns of Dosing Errors With Compounded Injectables

The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may...
Drugmakers Call for Changes, Additions to FDA’s Purple Book

USA – Drugmakers Call for Changes, Additions to FDA’s Purple Book

The US Food and Drug Administration’s (FDA) Purple Book for biosimilars needs some modifications and new information to be more useful, pharmaceutical companies told...
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment

USA – Clinical Trials: FDA Releases Two Draft Guidances

The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer...
Ibrance given NICE green light in breast cancer

USA – US green light for Pfizer’s lung cancer drug

The drug has been cleared under the brand name Vizimpro as a first-line treatment of patients with locally advanced or metastatic non-small cell lung...
Special 510(k)s: FDA Seeks Input to Expand Eligibility

USA – Special 510(k)s: FDA Seeks Input to Expand Eligibility

Device manufacturers have two months to help inform US Food and Drug Administration (FDA) draft guidance on its Special 510(k) Program. The 32-page draft guidance...
US FDA issues final rule for appealing medical device regulatory decisions

USA – Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

Drugmakers GlaxoSmithKline (GSK), Sanofi and Perrigo are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft...
Applied Tissue Technologies’ negative-pressure dressing gets FDA nod

USA – End of the eCTD? FDA Pushes for New KASA System to Improve...

The US Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee met Thursday to discuss the positive aspects of adopting a Knowledge-aided...

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