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FDA Lost That Lovin’ Feeling | Blog

The FDA lost its lovin’ feeling this week and we kept busy evaluating Louisiana’s new drug pricing proposal and watching not one, but two, Congressional hearings covering both Right to Try and the national opioid epidemic.


Social Rx Risk Retention - FDA Study | Blog

In 2014, the FDA mandated that a prescription drug’s benefit and risk information had to appear in its entirety when promoting via social media channels.


Communications Lessons from the FDA’s Approval of Biogen’s Aduhelm | Blog

Last month, in what was instantly hailed as one of the most controversial drug approvals in decades, the FDA granted accelerated approval to Biogen’s Aduhelm, the first new Alzheimer’s treatment to receive approval in nearly 20 years.


Patient USA: The FDA on Minorities and Clinical Trials | Blog

Martin Mendoza, Director of Extramural Research, Office of Minority Health at the FDA, shared a perspective on inclusion and diversity in clinical trials.


First COVID-19 Treatment Approved by FDA | Blog

The Food and Drug Administration (FDA) has approved the use of Veklury (remdesivir) for use in adult and adolescent patients 12 years of age and older for the treatment of COVID-19 in instances that require hospitalization.


The FDA's Newest Unit Looks Beyond Food and Drugs... | Blog

In a recent Wired article, Bakul Patel shared a glimpse into the new team he’s building within the FDA—completely focused on new developments in digital.


Apple Watch Accessory Receives FDA Approval | Blog

The FDA approved the first ever watch accessory, an Apple watch band that not only reads your EKG, but will communicate with your physician if results are abnormal.


With Recent FDA Approval, Bose Expands into the Healthcare Industry | Blog

Adding itself to the list of out-of-industry companies breaking into healthcare, Bose makes a big leap with FDA approval for its direct-to-consumer hearing aid.


FDA Considering Easing Side Effect Requirements in DTC Ads | Blog

Earlier this week, the FDA announced they are proposing a new study to look at whether patients are being bombarded and over-warned within direct to consumer prescription advertisements.


FDA Balancing Act | Blog

Ambitious technological innovation and the US healthcare system are two things that do not often logically go together.


The Week That Was: A Less Sharp FDA? | Blog

Ned Sharpless was just appointed Acting FDA Commissioner.


The FDA's Health & Medical App Enforcer = Apple App Store | Blog

Apple recently released a new detailed list of guidelines when it comes to developing health and medical apps that are helping the FDA enforce guidelines already in place.


Gene Therapy Innovation Now Guided by FDA | Blog

The advent of federal regulatory guidelines for developing gene therapies—which transplant new genes into people’s cells in order to correct disorders—is a crucial moment in the narrative of the still-novel treatment type.


Four Ways the FDA Is Making Communications Bettter | Blog

If you work in the pharmaceutical industry, you’ve probably been asked the big, exasperated question just about anyone who’s had to use healthcare communications asks: Why do you do it that way??


Apps to Push Prescription Drugs Over the Counter | Blog

In the first half of this new year, the United States FDA will incentivize many pharmaceutical brands to make their biggest prescription drugs available over the counter.


Advancing the Patient Voice in Clinical Trials | Blog

Recently, the FDA issued Collecting Comprehensive and Representative Input, the first of four patient-focused drug development (PFDD) guidance documents.


What Biogen’s Alzheimer’s Drug Approval Means for Life Sciences Companies | Blog

In a highly anticipated decision, the Food and Drug Administration (FDA) last week cleared Alzheimer’s disease drug aducanumab on an accelerated, conditional approval program.


What the lecanemab Approval Means for the Life Science Industry | Blog

The Food and Drug Administration (FDA) approved Alzheimer’s disease (AD) drug lecanemab through its accelerated approval program.


Biosimilar Elimination Red Tape Act | Blog

Mike Lee (R-UT) introduced the Biosimilar Elimination Red Tape Act that would prohibit the FDA from requiring that biosimilars undergo switching studies.


DPE15: Strategy Behind the Kim Kardashian Post | Blog

It’s not often that a social media strategy idea really goes viral – let alone gets 752 million social impressions, tens of thousands of interactions, international media coverage and a letter from the FDA.


AI + Patients: The Future Is Now | Blog

On January 26th, MIT spinoff Empatica received FDA clearance for its epilepsy-tracking Embrace Watch — making it the first smartwatch approved in neurology in the US.


How do you track your medicine? | Blog

The FDA announced exciting news this month.


Approved: First CBD-based Prescription Drug, for Treatment of Epilepsy | Blog

A landmark approval by the FDA will put the first marijuana-derived prescription drug behind pharmacy counters this fall.


Value & Outcomes Spotlight: Regulatory Policy and Real-World Evidence | In The Media

In this issue of "Value & Outcomes Spotlight" focused on Regulatory Policy and Real-World Evidence, Ruth Trzcienski, Compliance Director at inVentiv Health, talks about "FDA issues and their involvement with PhRMA and payers."


The Week That Was: No Rest for the Wicked | Blog

We’ve recapped Scott Gottlieb’s eventful penultimate week at the FDA in this week’s edition of The Week That Was.


Pharma & Payers - Opening the Lines of Communication | Blog

For the first time in 20 years, The FDA has issued new draft guidance on how pharmaceutical companies can communicate healthcare economic information (HCEI) with payers.


Medical-Science Moments by Dr. | Blog

This edition of Medical-Science Moments includes: FDA’s recent crackdown on dietary supplements, J&J leadership on drug pricing disclosure and human microbiome research.


From Cheers to Jeers; Stakeholders Scrutinize Price of Amylyx ALS treatment | Blog

Yesterday, there was widespread celebration across stakeholders following the FDA approval of Amylyx's treatment for ALS, Relyvrio.


Three Useful Healthcare Apps You Should Know | Blog

Our previous articles covered the definition of mobile medical apps and three examples of FDA-approved apps.


The Hero’s Journey Art Project: Using Social Media to Raise Awareness of Clinical Research – A Year Later Account | Blog

These patients represent the foundation of getting new and better treatments FDA-approved and in the hands of the patients that need them.