Language in FDA Decisions Could Signal Increased Scrutiny in Approval Decision-making
The wording in the US Food and Drug Administration’s (FDA) recent decision not to approve Pfizer and Myovant’s endometriosis application [...]
Fitbit Cleared by FDA for Afib Detection
The US Food and Drug Administration (FDA) has approved Fitbit’s algorithm for passive round the clock atrial fibrillation (afib) detection. [...]
Analysts: FDA’s Guidance on Gene Editing is Important, Albeit “Not Surprising”
While not surprised by the details of the FDA’s new guidance for gene editing in the biotech industry, analysts welcome [...]
Moderna seeks FDA Emergency Authorization for Children Under 6
Moderna touts new data supporting the use of its COVID-19 vaccine Spikevax in children under 6 as it prepares to [...]
ISPOR 2022 Plenary Session: HTA on the Run
Health Technology Assessment (HTA) agencies have accelerated their process in response to the COVID-19 pandemic. In a plenary session at [...]
FDA’s New Guidance on Real-World Data Spurs Questions from Pharma
Pharma and biotech companies have several questions for the FDA regarding the new guidance documents about real-world data (RWD) that [...]
Study: HealthCore’s Data Partnership Helped Drive the FDA’ Sentinel Initiative
The US Food and Drug Administration’s Sentinel Initiative tracks the safety of drugs, medical devices, and biologics on the market [...]
Advancing Real World Evidence Under FDA Commissioner Califf
As part of his new role as FDA Commissioner, Robert Califf has pledged to promote the use of real-world evidence [...]
Final Clinical Cancer Trial Guidances Issued By FDA
Three new final guidances for cancer trials have been released by the US Food and Drug Administration (FDA), which build [...]
7 Takeaways for Pharma from the FDA’s Quality System Guidance
Of all the guidances issued by the FDA, the “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations,” is [...]
FDA Will Propose Rules on the Distribution of Some Compound Drugs
Last Wednesday, the FDA annouced it would start the rule-making process to address the interstate transportation of compounded drugs. The [...]
FDA and Pfizer Step Away From COVID-19 Vaccine Expedited Review
The US Food and Drug Administration (FDA) and Pfizer are backing down from initial plans to fast-track approval of their [...]
Robert Califf Confirmed as FDA Commissioner
In a narrow 50-46 vote, Robert Califf has officially been confirmed as the Food and Drug Administrations new commissioner. This [...]
Whitepaper: What the New FDA Guidelines Mean for Patient-Reported Outcomes in Oncology Trials
The FDA has just released its draft guidance on oncology clinical trials using patient reported outcome measures (PROMS). The guidance [...]
Final Vote on Califf for FDA Commissioner
The Senate votes on the confirmation of Robert Califf for FDA Commissioner today amid ongoing political turmoil. Although largely divided [...]
Aetion Submits Comments on FDA’s Draft Guidance Electronic Health Records and Regulatory Decision-Making
Aetion submitted its comments to the FDA on their recent draft guidance regarding the use of real-world data to support [...]
Robert Califf’s Candidacy for FDA Commissioner Faces Uncertainty
The Biden Administration's nominee for FDA commissioner is on shaky ground as he faces skepticism from some Democrats and a [...]
2021 CDER Report: New Approvals Improve Patient Treatment Options
The Center for Drug Evaluation and Research (CDER) has released a new report detailing the 60 drugs the FDA approved [...]
FDA Approves New Heart Drug by Novartis
Novartis’s genetic drug Levqio was approved by the FDA in December, but hurdles remain for long-term sales. The drug, which [...]
FDA Warms Up to Real-World Evidence
The COVID-19 pandemic has shifted the FDA’s approach to real-world evidence (RWE) in a positive light, according to Stacy Cline [...]
Will Rob Califf’s industry ties sink his FDA commissioner nomination?
Dr. Rob Califf’s extensive industry ties cast uncertainty on his nomination for FDA commissioner. The nominee’s financial disclosures, released this [...]
Navigating the FDA Real-Time Oncology Review Process for Sponsors
Started in 2018, the FDA’s “Real-Time Oncology Review (ROTR)” project gives sponsors a head start on the application review [...]
New Report Considers Use of Oncology RWE in Successful Submissions to the FDA
In a recent article published in Clinical Cancer Research, investigators analyzed successful submissions of oncology drugs to the Food and [...]
Biden Picks Califf As Safe Bet for FDA Commissioner
Biden has nominated Robert Califf to lead the Food and Drug Administration (FDA). Although Califf’s position at Google’s Verily has [...]
MDIC Webinar on Cybersecurity and Medical Devices
The Medical Device Innovation Consortium (MDIC) has released an on-demand webinar on modeling cybersecurity threats for medical devices. The Food [...]
