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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.

FDA 60

FDA HIPAA Compliance 60

Healthcare It News

FEBRUARY 1, 2022

In contrast, however, according to the authors, women take a predominant role in health decisions and have about one-third higher health expenditures. BCG Digital Ventures was founded in 2014 as a multidisciplinary network of entrepreneurs, operators and investors. ” THE LARGER TREND.

COVID-19 219

COVID-19 FDA Health Insurance Doctors 219

Healthcare It News

FEBRUARY 1, 2022

In contrast, however, according to the authors, women take a predominant role in health decisions and have about one-third higher health expenditures. BCG Digital Ventures was founded in 2014 as a multidisciplinary network of entrepreneurs, operators and investors. ” THE LARGER TREND.

COVID-19 211

COVID-19 FDA Health Insurance Doctors 211

HIT Consultant

SEPTEMBER 7, 2021

About Gauss. Food and Drug Administration (FDA) in 2014, as the first-ever computer vision software for surgical use, and several follow-on 510(k) clearances. . – Triton combines the power of A.I. with the simplicity of a mobile device to deliver accurate blood loss during surgery.

FDA 97

FDA 97

Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

FDA 59

FDA Governance Medicare Medicare 59

Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.

FDA 52

FDA Compliance 52

HIT Consultant

JULY 31, 2023

Figure 2 showcases the VC funding landscape for digital pathology from 2014-2022. Figure 2: Public VC Funding for Digital Pathology Vendors 2014-2022 in USDM. Table 1: Topmost funded DP vendors 2014-2022. USD in 2022, with around 50% of that attributed to machine learning and more sophisticated algorithms.

COVID-19 96

COVID-19 FDA 96

Health Populi

FEBRUARY 21, 2023

Then it’s sleep and weight health consumers are most keen to track (for about one-half of those using health apps and tech’s), and then diet/food/counting calories (41%), and in fifth place, tracking blood pressure (for 36% of digital health tech users).

Medical Device Industry 62

Medical Device Industry Medicare Medicare FDA 62

Hall Render

JANUARY 3, 2024

Please join us in congratulating these individuals on this milestone and learn more about their respective practices below. from the University of Dayton School of Law in 2014. office and helps clients navigate the complex and ever-changing landscape of FDA regulation. Matt graduated with his J.D. Jennifer received her J.D.

Fraud 40

Fraud Hospitals Compliance FDA 40

HIT Consultant

DECEMBER 8, 2022

In 2014, a research team at Johns Hopkins found that U.S. – Streamlined delivery management and cart count processes, including support for multiple replenishment methods so staff can more easily capture product ID, expiration date and lot serial numbers, and quickly identify and verify locations as well as FDA-recalled items.

Hospitals 52

Hospitals FDA 52

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The measure may allow the expansion of the population’s access to diagnostic procedures in the country.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

JULY 8, 2022

complaints received about unexpected results (i.e., Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13. Teva Canada Ltd.,

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

DECEMBER 16, 2022

26 of 2014. The pilot project is open to applicants or MAHs that are about to submit MAAs or post-authorization applications. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

Public Advisory: Robikids and Solmux are Unauthorized Syrups for Thinning Mucus and May Pose Serious Health Risks, 03 March 2023 Health Canada is warning parents and caregivers about two unauthorized children’s syrups for thinning mucus, Robikids and Solmux, seized from Kamshoppe, which advertised the products on Facebook.

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 52

SQA

SEPTEMBER 2, 2022

Ma rketing authorization holders (MAHs) can now register their Industry Single Point of Contact (i-SPOC) who will inform EMA about the supply and availability of critical medicines identified in the context of a ‘public health emergency’ or a ‘major event’. United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. That’s broad, although arguably not as broad as FDA’s interpretation of it. The allure is obvious. Very brief.

FDA 98

FDA Licensing Hospitals Medicaid 98

Redox

MARCH 11, 2020

And the percent of US users climbed from 9% in 2014 to 33% in 2018, according to Accenture. Next-generation health trackers are more trustworthy than the consumer health bands that popped up a decade ago, with a growing number receiving FDA clearances. Supporting day-to-day clinical decisions.

Doctors 52

Doctors FDA Hospitals 52

SQA

AUGUST 2, 2021

The guide also provides information about the certification process, which will be helpful to any organization seeking to obtain certification or wanting to learn about the ISO 22000 certification process. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

FDA 52

FDA COVID-19 Compliance Governance 52

SQA

FEBRUARY 26, 2024

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. The products found, subject to retention and seizure, were retained by the Federal Revenue Service.

FDA 52

FDA Compliance COVID-19 Public Health 52

Kaiser Health News

JUNE 2, 2022

when the FDA approved mifepristone in 2000. Some legal and drug regulatory experts argue that because the FDA is the federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs, states wouldn’t have the power to overrule its stamp of approval and outlaw the abortion pill.

FDA 83

FDA Public Health Governance 83

Health Law Advisor

MAY 3, 2022

Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. As a result, I start by looking at the rate of inspection citations compared to the rate of warning letters to see what it might tell us about the underlying data. That produced about 40,000 inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

DECEMBER 4, 2023

On a host of issues, CPAP II makes a recommendations about state law – but without any basis in existing state law. Undisputedly, the complaint at issue “allege[d] no specific facts about any specific plaintiffs or specific injuries.” 28, 2023) (“ CPAP II ”), is entirely Mr. Hyde. 2023 WL 7019287, at *3. 2023 WL 7019287, at *3.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 273, 288 (2014); PLIVA, Inc. That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he Medtronic, Inc. ,

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

Fraud 52

Fraud FDA Doctors 52

Drug & Device Law

NOVEMBER 10, 2023

Two of your intrepid bloggers took shots at writing blogposts about Valsartan shortly after it was decided – but found the opinion simply too complicated, verbose, and depressingly wrong for us to wrap our hands, or our brains, around. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

MARCH 3, 2022

In the coming weeks, there are sure to be many articles looking at what Judge Brown Jackson has written and what that might suggest about the future jurisprudence of the United States Supreme Court if she is confirmed. By contrast, Judge Jackson has written about preemption in the context of a device product liability case.

FDA 59

FDA Fraud Governance 59

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). allegations of failure to report adverse events to the FDA. The appeal remains pending.

FDA 59

FDA 59

Drug & Device Law

JANUARY 15, 2024

First , the none of what you just read about the Supreme Court decision in Sullivan is precedential in Pennsylvania. We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 2d 590 (Pa. 3d 328 (Pa.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

JUNE 2, 2022

We are just simple defense hacks writing about product liability law and some other things that matter to medical product manufacturers. Although the male authors here agree wholeheartedly that individual choices about women’s contraception, reproduction, and sexual health are not for us to make.) As we discussed here , McCormack v.

FDA 127

FDA Licensing 127

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir. label, he would still have prescribed [the drug] to [plaintiff]. . . .

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MARCH 7, 2022

Gloucester County , 2014 WL 1599499, at *3 (D.N.J. April 21, 2014). These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., That’s a start, but what about the federal courts of appeals? 2014 WL 12787639, at *10 (C.D. 2014 WL 12717702, at *13 (D.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

DECEMBER 28, 2023

It is not uncommon that terms are used without knowledge of their origin and that the origin is instructive about the meaning or proper application of the term. But note that this was not about evaluating whether there was any association between an exposure and an outcome each drawn from the proverbial hat. We offer two examples.

FDA 52

FDA World Health Public Health 52

Drug & Device Law

FEBRUARY 2, 2023

2014) (applying Texas law). Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Toyota Motor Engineering & Manufacturing North America, Inc. ,

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

MAY 12, 2022

We do not care much about car racing. When we heard a presentation last week from a Formula 1 executive, we paid it about as much attention as we pay most presentations in a room full of hundreds of lawyers. We have commented a number of times about problems with the MDL system in general and in those MDLs in particular.

FDA 59

FDA 59

Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 871 (9th Cir.

Informed Consent 59

Informed Consent FDA Doctors 59