FDA Law

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

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Hospital Manufacturing Specialization Medical 52

FDA Law

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. By Steven J. Gonzalez & Lisa M.

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FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. Nevertheless, the Agency believes this bifurcated system presents public health risks, and needs to be corrected by bringing LDTs under the FDA’s general IVD regulatory framework.

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CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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Manufacturing Engineering Medical IT 64

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Patients Clinic 120

FDA Law

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. These clearances are based on short-term (30 day) patient follow up.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S. 101, also seems pretty good on paper.

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IT Manufacturing Medical Provider 76

FDA Law

OCTOBER 14, 2024

At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF).

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Clinic Patient-Centered Asthma Patients 59

FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

Manufacturing 40

Manufacturing IT Medical Individual 40

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. FDA, Performance Report to Congress: Medical Device User Fee Amendments FY 2022, at 13-18, [link]. [14]

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers. By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e.,

Specialization 40

Specialization Clinic Provider IT 40

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M. 360e-3)).”

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

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Illness IT Patient-Centered Patients 107

FDA Law

FEBRUARY 22, 2022

We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients are included. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

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Manufacturing Screening Provider Clinic 52

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. While that observation is intended as praise for the TAP Pilot, it can be considered a sad commentary on the general state of manufacturer-CDRH interactions.)

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Manufacturing Medical Appointment Patient-Centered 45

GeriPal

MARCH 24, 2022

And I don’t think necessarily, that appointment needs to be a medicalized process. But I think just like patients need their own preparation, really it’s the surrogate that we often leave out of these discussions, especially early on. And that surrogate as you’re all saying might be in the context of multiple people.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. Currently Accepted Medical Use in Treatment in the U.S. 21 U.S.C. § 21 U.S.C. §

Physicals 69

Physicals Medical Clinic Emergency Room 69

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. This influenza infection primarily presents in cattle as decreased milk production, lethargy, and decreased appetite. For the public, cautious monitoring is recommended.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

Tiny Physician

OCTOBER 17, 2021

Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). It is worth noting that Covaxin, our indigenously developed vaccine manufactured by Bharat Biotech, is on the verge of getting approval in the pediatric age group as well (6).

Vaccination 52

Vaccination Government IT Physicals 52

FDA Law

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

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Insurance Patients Manufacturing Patient-Centered 83

FDA Law

JUNE 1, 2025

Commissioner Makary has taken a more subdued stance, stating in a podcast with Megyn Kelly that FDA doesnt have any plans to ban direct-to-consumer advertising, but there are some things that we can do to make sure that the information being presented is a complete picture.

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Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. By Dara Katcher Levy & Sara W. Koblitz & Jeffrey N. Please bear with us.) it is illegal to import. FDC Act 804(j)(1), (2).

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Manufacturing IT Provider Individual 59

FDA Law

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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Medical Manufacturing Patient-Centered Provider 59