STAT

DECEMBER 30, 2024

  The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been approved between 1978-2024 and had accessible information about performance testing.

Documentation 141

Documentation FDA 141

Pharmacy Times

AUGUST 8, 2023

Improved prescription information could help consumers make better health care decisions and result in cost savings.

FDA 123

FDA 123

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. We have recently blogged on this topic (“ Is my software a medical device? ”).

FDA 105

FDA Documentation Labelling Communication 105

Drug Topics

JUNE 11, 2024

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses how some of the concern’s raised by the panel can inform future psychedelic research.

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FDA 216

Pharmacy Times

JANUARY 7, 2025

Despite these concerns, experts have emphasized that the benefits of RSV vaccination outweigh potential risks for older adults, who are at heightened risk of severe RSV-related illness.

Vaccines 139

Vaccines FDA 139

The FDA Law Blog

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed.

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FDA Communication Dosage 105

STAT

APRIL 1, 2025

“I regret to inform you that you have been affected by a reduction in force (RIF) action,” an email to affected employees said. It went on to tell the recipients that they were placed on immediate administrative leave, offering no details of the length of that leave.

FDA 145

FDA 145

The FDA Law Blog

JUNE 26, 2024

Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.

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FDA Labelling Packaging 98

STAT

JANUARY 22, 2024

Having all of these details in accessible, printed documents keeps patients informed and mitigates the risk of medication errors. However, there’s a growing movement across the world to eliminate printed medication information, making it harder for patients to learn about the drugs that, in many cases, save their lives.

Documentation 110

Documentation FDA 110

The FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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FDA Communication Documentation 111

STAT

JANUARY 22, 2024

But the FDA is behind on something crucial: It needs to develop and clarify regulations to protect patients from potential harm and misleading information on social media platforms, particularly from influencers. More recently, in December the agency published guidance about TV and radio advertisements. Read the rest…

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FDA 144

STAT

SEPTEMBER 25, 2023

BrainStorm filed for approval over the FDA’s protest, insisting that NurOwn has demonstrated benefits for a subset of ALS patients with milder disease.

FDA 138

FDA Documentation 138

pharmaphorum

MAY 18, 2022

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Current FDA Commissioner Robert Califf spent some time as an advisor to Google parent Alphabet after his earlier stint at the head of the regulator. Bakul Patel.

FDA 139

FDA 139

STAT

JUNE 28, 2024

Rocket Pharmaceuticals said Friday that the Food and Drug Administration rejected its gene therapy for an ultra-rare, sometimes fatal immuno-deficiency syndrome, saying the company needed to submit more information to prove it can safely manufacture the product.

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FDA Immunization 124

STAT

JANUARY 16, 2024

In her final presentation for health policy class at the University of Chicago, first-year medical student Robin Ji informed her classmates that the Food and Drug Administration does not require randomized controlled trials of most medical devices. Her peers’ immediate reaction was disbelief.

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FDA Medical Schools 141

STAT

FEBRUARY 15, 2024

Though those websites say their chemicals are “for research use” and “not for human consumption,” the FDA said it found evidence on their pages showing that their products are indeed intended for human use, such as information about dosing and claims about the clinical benefits of the products.

FDA 137

FDA 137

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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FDA Documentation 135

STAT

OCTOBER 17, 2023

Patient safety is paramount to the FDA, so stopping Cassava’s two Phase 3 studies is the ethically correct thing to do. The FDA has the power to place clinical holds on experimental drugs when there’s evidence of an unacceptable safety risk to study participants. Simufilam doesn’t appear to be toxic.

FDA 141

FDA 141

The Checkup by Singlecare

JANUARY 15, 2025

Food and Drug Administration (FDA), such as Rybelsus (oral semaglutide), Mounjaro (tirzepatide), Zepbound (tirzepatide), and Saxenda (liraglutide). While a regular pharmacy dispenses commercially manufactured FDA-approved medications, compounding pharmacies prepare customized medications tailored to individual patient needs, says Eric F.

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Compounding Compounding Pharmacies FDA Dosage 98

STAT

OCTOBER 1, 2024

Yet, for too long, I had no idea the Food and Drug Administration convenes groups of experts, known as advisory committees or ad comms, to review trial data for treatments and make recommendations to inform the FDA’s regulatory decision-making. They review the safety and efficacy of medical products.

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FDA 104

The Checkup by Singlecare

NOVEMBER 9, 2023

Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.

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FDA Labelling Insurance 120

STAT

AUGUST 20, 2024

And a group of researchers — including two from the FDA’s Center for Drug Evaluation and Research — think artificial intelligence could uncover more signs of these issues, including from electronic health records, social media posts, and clinical databases referencing certain drugs.  

FDA 134

FDA Communication Labelling Insurance 134

Pharmacy Times

JANUARY 17, 2025

If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.

Packaging 144

Packaging Labelling FDA 144

The Checkup by Singlecare

JANUARY 9, 2025

Food and Drug Administration (FDA). Why and when semaglutide is compounded According to the FDA, compounded drugs are made by licensed pharmacists (or under the supervision of pharmacists in outsourcing facilities) who combine, mix, or alter ingredients of a drug. There are a few times when compounding is necessary.

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Compounding Compounding Pharmacies FDA Sterile Compounds 104

STAT

NOVEMBER 14, 2024

The agency, for example, cited an Instagram post on an account belonging to Nate Berkus, a prominent interior designer, which highlighted various benefits but made it very difficult for consumers to read information about any risks. The FDA argued this is unlikely to get the attention of a viewer.

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FDA Pharmaceutical Companies Pharmaceutical Companies 112

STAT

APRIL 1, 2024

Researchers hypothesize that the technique targets the brain’s dorsolateral prefrontal cortex and the amygdala and may “enhance cognitive control over emotional information processing.” ” Patients also receive cognitive behavioral therapy.

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FDA Insurance 143

The FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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FDA Labelling 105

European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. On 2 May 2023, the FDA published draft guidance which included recommendations for delivering decentralised clinical trials.

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FDA Communication 104

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The post US FDA grants Fast Track status for Pfizer-BioNTech’s combination vaccine appeared first on Pharmaceutical Technology.

Vaccines 115

Vaccines FDA Communication 115

The FDA Law Blog

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Labelling Dosage 104

STAT

OCTOBER 20, 2023

The list of AI devices was first published after a STAT investigation reported that the FDA had failed to keep the public informed on its regulation of AI devices, or crucial details on the tests undertaken to prove their safety and effectiveness.

FDA 123

FDA Documentation 123

The Checkup by Singlecare

NOVEMBER 6, 2023

Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response. How much will Wezlana cost?

FDA 110

FDA Immunization 110

The Checkup by Singlecare

NOVEMBER 11, 2024

As a brand-name prescription drug, Lexapro is FDA -approved to treat major depressive disorder and anxiety disorders. Although trazodone is FDA -approved for depression, it’s primarily known for its off-label use as a sleep aid due to its sedative effects.

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FDA Labelling 94

Pharma Marketing Network

MARCH 8, 2025

It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. Patient Awareness: Helps provide disease information, medication adherence tips, and support program details. Avoid misleading claims Always align with FDA-approved language.

HIPAA 59

HIPAA FDA Communication 59

European Pharmaceutical Review

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.

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FDA Communication Packaging 105

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

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FDA Documentation Method Validation Packaging 98

The FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

FDA 105

FDA 105