FDA Law Blog

AUGUST 7, 2023

Site visits can also provide the opportunity to engage with patients on various topics, such as prototyping, trial design and conduct, and product launch and understand the challenges related to quality systems development and management in the product life cycle.

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FDA Law Blog

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

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FDA Law Blog

FEBRUARY 15, 2023

Further, radiation emitting products are used in limited circumstances, such as to answer a clinical question or guide disease treatment. It is expected that, during these instances, patient risk from radiation exposure can be mitigated and minimized. The final rule will be effective February 21, 2023.

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FDA Law Blog

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

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FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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FDA Law Blog

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. The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study.

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FDA Law Blog

DECEMBER 11, 2023

In fact, as of November 2023, the CMS’s Standards and Certification’s (S&C’s) Quality, Certification and Oversight Reports (QCOR) CLIA Laboratory Lookup Database shows 17,206 CLIA-certified laboratories. This is based on FDA’s reported 2018 review of the CLIA database. [2] of 510(k) decisions, respectively. [13]

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

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FDA Law Blog

FEBRUARY 1, 2022

Another commenter suggested that FDA limit listable patents only “to patents protecting innovations that improve health and have been demonstrated to do so through clinical testing.” FDA addressed each inquiry and responsive comments in turn, but the comments overall were similar—everyone has different ideas.

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FDA Law Blog

MAY 19, 2023

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., analytical, clinical and stability).

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Siddiqui October 31, 2023 Summary : This episode highlights the culture of food shaming and anti-fatness as it relates to anti-Blackness. Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. During this episode, we hear from Da’Shaun L.

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FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. Kirschenbaum & Sophia R.

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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.

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FDA Law Blog

MAY 5, 2024

29, 2023). FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. Unlike its 2016 analysis, FDA’s/HHS’ 2023 analysis considers marijuana to have a currently accepted medical use in treatment in the U.S. Letter to U.S.

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

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FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

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FDA Law Blog

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

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FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

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FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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FDA Law Blog

MAY 21, 2024

29, 2023) (“Basis”); NPRM at 44,603. DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614. NPRM at 44,617.

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FDA Law Blog

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

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FDA Law Blog

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Dr. Baron spoke to specific actions sponsors can take to improve representation of women in cardiac clinical trials.

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