Bill of Health

MARCH 12, 2024

Yet, once approved, FDA will put limits on the approved drug. The MDMA NDA Back in December 2023, Lykos Therapeutics (formerly MAPS PBC ) submitted a New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), which FDA recently granted priority review.

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Healthcare Dive

JANUARY 6, 2023

Yet experts have raised concerns about its safety. The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression.

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Bill of Health

OCTOBER 14, 2022

The 21 st Century Cures Act (passed in 2016) recommends the use of RWD to support FDA decision-making about product approvals. While RCTs are considered the “gold standard” for generating evidence about a product’s safety and efficacy, RWD can supplement RCT results. Generating hypotheses or informing the design of a later RCT.

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Health Law Advisor

MARCH 14, 2023

Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.” EBG will continue to monitor additions and other updates to the Directory.

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Healthcare Dive

JUNE 30, 2022

A standard clearance could further broaden Paxlovid’s fast-rising use. But weaknesses are emerging too, among them unclear benefits in vaccinated people and a potential lack of potency against new variants.

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Healthcare IT News - Telehealth

DECEMBER 20, 2021

"The in-person dispensing requirements on medication abortion care have proven to be unnecessary during the pandemic, and the FDA did the right thing today by lifting them," said Kirsten Moore, director of the Expanding Medication Abortion Access Project, in a statement.

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HIT Consultant

AUGUST 29, 2022

In 2022, the FDA ( Federal Food and Drug Administration ) will clear or approve over 1,000 medical devices. Here’s a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some of these new FDA medical devices will truly impress you. PMA Applicant: Allergan.

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Dot Compliance

FEBRUARY 15, 2024

On January 31st, 2024, almost a year after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule. director of the FDA’s Center for Devices and Radiological Health. What Is QMSR?

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Bill of Health

NOVEMBER 29, 2023

By Vincent Joralemon Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Pfizer’s successful clinical trials for ED followed, leading to FDA approval of sildenafil citrate, marketed as “Viagra,” in 1998. This became Spravato, the first FDA-approved psychedelic therapy. Bob Dole even endorsed it.

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Healthcare Dive

FEBRUARY 1, 2022

Different manufacturers have lined up on opposite sides of a debate about key aspects of the agency's proposed rule that would create a new category of over-the-counter hearing aids.

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Healthcare Dive

JULY 13, 2022

The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.

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Dot Compliance

NOVEMBER 2, 2022

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, [link] cd/inspections.htm ). In its February 2022 report, the U.S.

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Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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Bill of Health

MARCH 4, 2024

It makes sense for a company to push for regulations that help their business, and organizations often have a lot better knowledge than policymakers about how to regulate their own industries efficiently. A company could always try to stay out of conversations about governmental policies, but that risks having their concerns ignored.

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Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking about. You can read about the words that defined topic 10 in the table above.

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Bill of Health

APRIL 24, 2023

Dmitry’s talk, “Evergreening: The FDA’s Role in the Creation of Balanced Rights for Pharmaceutical Improvements,” was developed into an article and published in the Iowa Law Review in 2019 titled “The More Things Change: Improvement Patents, Drug Modifications, and the FDA.”

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Bill of Health

OCTOBER 6, 2023

Think about it: a psychedelic “trip” can take several hours. The FDA approved S-ketamine to treat depression in 2019. Compare those prices to those charged by Joyous, a telehealth company that ships ketamine directly to customers for about $130 per month. But that is just the cost of the actual drugs.

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Dot Compliance

NOVEMBER 20, 2023

Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards. Understanding the Basics: 21 CFR Part 210 and 21 CFR Part 211 are the cornerstones of the FDA’s cGMP regulations for the pharmaceutical industry. Manufacturers must adhere to stringent regulations set forth by the U.S.

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Health Law Advisor

MARCH 3, 2023

Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. [1] However, FDA found that consumers do not appear to understand the nutritional differences between plant-based milk and cow-derived milk. On February 22, 2023, the U.S.

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Healthcare Dive

MARCH 23, 2022

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge.

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HIT Consultant

SEPTEMBER 12, 2021

And that’s just what we can see has been “posted” on the FDA site through June 25, 2021. The FDA has noted that recalled medical devices caused almost 100,000 deaths between 2008 and 2021 — but before and after this time period ? I was once in a hospital operating room, scanning cement that was about to be used in surgery.

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Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. Only about 2100 get resolved in the first 20 days, or about 18%.

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Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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HIT Consultant

JULY 22, 2022

What You Should Know: – Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. The Zio Watch uses continuous photoplethysmography (PPG), an AI-based algorithm to detect AFib and calculate an AFib burden estimate.

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Health Law Advisor

JANUARY 31, 2023

On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.” Becerra.” [1] Becerra.” [1]

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HealthIT Answers

OCTOBER 11, 2022

Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical. The post FDA Further Harmonizing Clinical Research Regulations with HHS Common Rule appeared first on Health IT Answers.

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Health plans offering the OTC benefit can also leverage the opportunity to educate members about the significant role hearing aids can play in improving their overall health. About Thomas Tedeschi. – What new opportunities will arise? Educating members.

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FDA Public Health Medicare Medicare 98

Bill of Health

NOVEMBER 30, 2022

Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public. State pharmaceutical bans and restrictions — which are often medically unnecessary and instead based largely on policymakers’ moral and political views — impede the FDA’s mandate to protect and promote the public health.

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Healthcare It News

SEPTEMBER 2, 2022

FDA draft guidance from this past April, on enrolling more participants from underrepresented racial and ethnic populations in the U.S. Like what you hear? Subscribe to the podcast on Apple Podcasts , Spotify or Google Play ! Vibrent Health and how it's working on this initiative. into clinical trials.

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Dot Compliance

NOVEMBER 2, 2022

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. Without FDA notification, companies may get this paper in the mail.

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HIPAA Journal

JUNE 1, 2022

BD has issued security advisories about two vulnerabilities that affect certain BD Pyxis automated medication dispensing system products and the BD Synapsys microbiology informatics software platform. BD has alerted CISA, the FDA, and ISACs about the vulnerabilities under its responsible vulnerability disclosure policy.

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

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Kaiser Permanente

JANUARY 21, 2022

Pharmaceutical marketing aims to shape perceptions about a drug’s benefits and harms, and this can significantly impact providers’ decisions about patient care. The post How pharmaceutical marketing affects decisions about patient care appeared first on Kaiser Permanente Institute for Health Policy.

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Bill of Health

DECEMBER 20, 2022

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

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Florida Health Care Law Firm

MAY 5, 2022

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil. As long as they don’t market essential oils as if they are medicine or a cure for any issue, they can otherwise say what they like about the products.

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Healthcare Dive

APRIL 7, 2022

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

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Mobi Health News

APRIL 26, 2018

This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD).

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