Physician's Weekly

JUNE 17, 2025

But the FDA has never approved it for any medical condition in the U.S. Calello explained that it falls under a gray area of consumer supplements or products that are not regulated or tested the same way a medication would be. The FDA sent a warning letter to the maker of a product called Tianna in 2018.

Medical 52

Medical IT Hospital Government 52

The Medical Futurist

JUNE 21, 2025

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. The Stanford Artificial Retina Project shows great promises.

Diabetes 98

Diabetes Patient-Centered IT Patients 98

Physician's Weekly

JUNE 25, 2025

It’s “going to streamline it in some incremental ways only,” Dr. Adam Gaffney , a critical care doctor and assistant professor at Harvard Medical School, told NBC News. Insurers must provide clearer explanations when care is denied and explain how patients can appeal.

52

52

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). By McKenzie E.

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda.

Manufacturing 105

Manufacturing Management Medical Provider 105

PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. 2018 Nov 22;379(21):2002-2014.

Hospital 105

Hospital Illness Patients Provider 105

My Green Doctor

APRIL 4, 2025

New Research: Teaching Patients about Climate Resilience Newly published original research co-authored by My Green Doctor’s Dr. Todd Sack concludes that, “ the medical office waiting room appears to be an accepted, time-efficient, and effective site to communicate knowledge on climate change and health. ” Contact us today! of total U.S.

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

The Clinical Problem Solvers

OCTOBER 18, 2022

Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration. Correctional officers act as gatekeepers, deciding who does and does not need medical care.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). By McKenzie E.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

OCTOBER 4, 2022

By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. This acknowledgment will include an FDA-assigned identification number for the allegation report.

Manufacturing 52

Manufacturing Medical Provider IT 52

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. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111

Medical Clinic Patients IT 111

Aspiring Minority Doctor

MARCH 14, 2022

For those who aren’t aware, today is Match Day where thousands of 4th year medical students and graduates find out if they have secured a residency position. For many, this is a joyous day filled with celebrations and sighs of relief, but for the unmatched, this can be one of the most depressing experiences of an entire medical school career.

Medical Student 52

Medical Student Medical Management IT 52

Medical Xpress

JANUARY 27, 2023

She researched rural states facing a shortage of behavioral health providers and accepted a job as a lead clinical primary therapist at Shodair Children's Hospital in Helena, Montana, in January 2018.

Hospital 70

Hospital Clinic Provider Medical 70

FDA Law Blog

AUGUST 2, 2022

As a reminder, cannabis remains a schedule I substance under the federal Controlled Substances Act (“CSA”), which by definition means it does not have an accepted medical use in treatment in the United States and thus cannot be legally sold or marketed for any purpose. Cole providing guidance to U.S. 21 U.S.C. § 812(b)(1).

Medical 96

Medical Individual Provider Community 96

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

Diagnosis 59

Diagnosis Clinic Provider IT 59

FDA Law Blog

JULY 7, 2021

Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In 2018, a Massachusetts court upheld the use of GEDs in treating patients with SIB/AB, finding the device to be effective in treating refractory patients.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

Consulting 52

Consulting Medical Management Specialization 52

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Discuss options like oral medications, intranasal routes, or the presence of trusted caregivers during procedures.

Family 77

Family Families Patient-Centered Physicals 77

FDA Law Blog

OCTOBER 5, 2022

For additional information on the structure and referenced guidance documents, please refer to Table 1 of the Electronic Submission Template for Medical Device 510(k) Submissions guidance document.) The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps. add-to-files).

Electronics 45

Electronics Medical Screening IT 45

FDA Law Blog

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

Clinic 98

Clinic Provider IT Patients 98

FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

Consulting 52

Consulting Manufacturing Utilities Provider 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Medical 64

Medical Electronics Manufacturing Utilities 64

BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. Shaanxi, Xi’an, China: Shaanxi Normal University; 2018. 皖南医学院学报 [J Wannan Med Coll] 2010;29(05):391–94.

Community 40

Community Individual Physicals Finance 40

FDA Law Blog

DECEMBER 13, 2023

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. There are hundreds of known genetic metabolic diseases, most of which are rare and carry significant morbidity.

Patient-Centered 59

Patient-Centered Medical Patients IT 59

FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

MAY 2, 2022

Marijuana is legal for medical use in 37 states, and for recreational use by adults in 18 states, but the drug remains a federal schedule I substance. In response to states authorizing and legalizing marijuana while it remained a schedule I substance federally, Deputy Attorney General James Cole provided guidance in a memorandum to U.S.

Manufacturing 52

Manufacturing Medical IT Community 52

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

Provider 59

Provider IT Consulting Medical 59

FDA Law Blog

MARCH 6, 2022

The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems. FDA initially announced this plan in 2018, and it has previously appeared in FDA’s regulatory agenda.

Manufacturing 52

Manufacturing Management Medical Provider 52

FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

MAY 25, 2022

The safety communication acknowledges that the tests “may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality.” However, even with a low PPV, a test can provide clinically useful information to providers and patients.

Provider 40

Provider Screening Medical Patients 40

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52