FDA Issues Draft Guidance Recognizing the Role of Real-World Evidence in Learning More about Populations Underrepresented in Clinical Trials for Drugs and Biological Products
By: Ulka Campbell, Head of Scientific Strategy, Aetion Of the many potential use cases for real-world data (RWD) [...]
FDA Faces Pressure Over Aduhelm Approval
A US congressional report released this week noted that the Food and Drug Administration (FDA) failed to heed its own advice when approving Aduhelm, a controversial treatment for Alzheimer’s disease. The report blamed the agency for overlooking key issues with data surrounding the drug’s actual clinical efficacy. In addition, it lambasted Biogen, the drug’s manufacturer, for the exorbitant price tag.
FDA Commissioner Califf Introduces Overdose Prevention Framework
Commissioner Rob Califf discussed the US Food and Drug Administration’s (FDA) approach to the opioid crisis and how the agency will pivot in the near future. In the blog post, he noted that the FDA needs to reevaluate the metrics it uses to study safe usage guidelines for opioids. The agency will pursue this goal with its new Overdose Prevention Framework, which seeks to reduce overdoses with a multi-pronged approach.
FDA Commissioner Rob Califf Says Agency Will Advance New Evidence Generation System
During a Zoom event on Tuesday, June 12th, Food and Drug Administration (FDA) Commissioner Robert Califf told members of the [...]
Vin Gupta in the Lead for FDA Medical Advisor Role
The US Food and Drug Administration (FDA) is looking for a new principle medical adviser to take charge of public [...]
FDA Gives Amylyx’s ALS Drug a Second Chance
Amylyx’s application for its ALS drug was narrowly shot down by FDA advisors earlier this year because they were not [...]
Fagron Group API Facility Receives FDA Warning Over Cleaning Issues
The US Food and Drug Administration (FDA) has issued a warning letter to an active product ingredient (API) facility run [...]
New FDA Proposal Would Expand Access to Nonprescription Medications
A new proposal by the FDA lays out new requirements to expand the use of a non-prescription drug to additional [...]
FDA Will Present Draft Guidance on Real-World Evidence in Grand Rounds on June 22nd
The US Food and Drug Administration will unveil its highly anticipated draft guidance on real-world evidence this Friday, June 24th. [...]
Breaking: US FDA Approves Moderna and Pfizer’s COVID-19 Vaccines for Children 5 and Under
The US Food and Drug Administration’s (FDA) vaccine advisory committee (Adcomm) voted unanimously (21-0) to approve Moderna and Pfizer’s mRNA-based [...]
FDA Vocalizes Support for Moderna and Pfizer Vaccines for Children Under 5 One Day Before Advisory Committee
The US Food and Drug Administration (FDA) has signalled support for authorizing the Moderna and Pfizer COVID-19 vaccines for children [...]
CMC – Gene Therapy’s “Achilles Heel”
Patient access to novel gene therapies is often obstructed by manufacturing challenges, in particular, issues with Chemical, Manufacturing and Controls [...]
Novavax COVID-19 Vaccine Awaits FDA Review of Manufacturing Data
On Tuesday, outside experts at the US Food and Drug Administration (FDA) voted 21 – 0 to give emergency approval [...]
Emergent and J&J Butt Heads Over Breaches of Contract
On Monday, June 6th, Emergent BioSolutions informed Johnson & Johnson that it will owe $420 million if the company terminates [...]
US Senate Advances its Version of Accelerated Approval Reforms
Right on the heels of similar legislation in the US House of Representatives, the Senate is pushing forward its version [...]
Podcast Q&A: FDA Guidance Documents: Shaping the Future of RWD Curation and RWE Innovation
This podcast segment features the Q&A from IQVIA's May 25, 2022 webinar hosted IQVIA experts Raina Olexa, Senior Principal Scientist [...]
Over 120 Deaths and 21,000 Complaints Accrue in Year after Philips’ Ventilator Foam Recall
Last April, Philips reported quality issues in the sound-reducing foam used in many respiratory aids, including ventilators, CPAP, and BiPAP [...]
Voluntary Recall Guidance Released by FDA
The US Food and Drug Administration (FDA) issued its final guidance in April on initiating voluntary recalls for drugs, biologics, [...]
UCB’s Psoriasis Drug’s FDA Application on Pause Due to Facility Inspection Issues
The US Food and Drug Administration (FDA) has temporarily halted the approval process for UCB’s psoriasis drug bimekizumab on concerns [...]
FDA Approves Eli Lilly Diabetes Drug
The US Food and Drug Administration (FDA) has given the green light to Eli Lilly’s new type II diabetes therapy [...]
Cytel Announces Free Statistical Programming Ebook
When submitting data to the US Food and Drug Administration, maintaining a steady line of communications is essential. Frequent [...]
FDA Roundup – Week of May 10th
In the latest weekly FDA roundup, the agency has approved the immunomodulatory COVID-19 drug for use in hospitalized adult patients [...]
FDA Creates New Training Program for mRNA Vaccine Manufacturing Inspectors
As mRNA technology has been thrust into the mainstream with the advent of COVID-19 vaccines, the US Food and Drug [...]
CDER Director Requests Accelerated Approval Reforms and Expresses Worries over Recent Court Decisions
Patrizia Cavazzoni aired her concerns about recent court cases and made requests regarding accelerated approval reform in a recent hearing [...]
Webinar: Lessons Learned from Inspections and Audits During COVID-19
While the efforts and procedures of many regulatory bodies ground to a halt during the COVID-19 pandemic, the US Food [...]