The Medical Futurist

JUNE 21, 2025

Compared to that, our hearing only processes 11 percent of information, while smell 3.5 Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. percent, touch 1.5 percent and taste 1 percent. Don’t you think that’s possible? Renowned scholars, L.D. How far can you see and hear? Globally 1.1

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Diabetes Patient-Centered IT Patients 105

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop.

Medical 23

Medical Manufacturing Electronics Provider 23

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. This guidance document is still in effect today. use in education, construction, art, and jewelry).

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Medical Manufacturing Healthcare Government 98

FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3)

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Manufacturing Provider Medical IT 98

FDA Law Blog

FEBRUARY 7, 2023

Part 814), and for conducting clinical trials (21 C.F.R. For PMA devices, the marketing application contains quality system and manufacturing information, so getting started on the quality system in parallel to device development is important for a timely submission. Part 807, Subpart E), De Novo authorization (21 C.F.R.

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Manufacturing Medical Engineering IT 98

FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

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Manufacturing Medical Provider Clinic 105

FDA Law Blog

NOVEMBER 29, 2023

The evidence used to measure the device’s performance should be scientifically and clinically justified, consistent with the level of risk for the proposed change. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.

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Management Manufacturing Medical Healthcare 115

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Manufacturing Engineering Clinic Provider 59

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. This guidance document is still in effect today. use in education, construction, art, and jewelry).

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Medical Manufacturing Healthcare Government 75

FDA Law Blog

MARCH 3, 2024

Biotechnology services include advising or consulting services related to the use of the above equipment, disease detection, or genealogical information, or any other service for the research, development production, analysis, detection, or provision of information including data storage and transmission related to biological materials.

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Manufacturing Government Consulting IT 102

FDA Law Blog

NOVEMBER 1, 2022

USP aims to identify tools and solutions that may facilitate CART therapy development and mentioned potentially writing an information chapter on developing assays for CART therapies based on the workshop’s panel discussion. Agency often sees issues when the drug product is put on an expedited manufacturing or an expedited clinical program.

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Manufacturing Clinic Provider IT 59

FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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Patients Clinic Medical Patient-Centered 52

FDA Law Blog

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Manufacturers should, therefore, welcome any additional source of examples of device changes to aid in evaluating their own.

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Manufacturing Provider Consulting IT 64

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. This time around several suggestions were raised. I suggested even flow.

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IT Patient-Centered Patients Clinic 120

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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Provider Medical Manufacturing Consulting 59

FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. After reviewing the information. This broad scope is curious. What is going on here?

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Manufacturing Provider Patients Medical 52

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law Blog

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law Blog

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).

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Manufacturing Clinic Engineering Individual 52

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. 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

CDOCS

MAY 4, 2021

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & The possible complications were communicated so that the patient could make an informed decision and proceed with treatment.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

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Clinic Manufacturing Patients IT 52

FDA Law Blog

SEPTEMBER 18, 2024

However, there is a continuing disagreement between FDA and industry about how that phrase should be read with the phrase “and for which substantial clinical investigations have been institute and for which the existence of such investigations has been made public.”

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Manufacturing Clinic IT Provider 59

FDA Law Blog

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

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Clinic Provider IT Electronics 59

FDA Law Blog

MARCH 1, 2023

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility.

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

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IT Screening Hospital Clinic 102

FDA Law Blog

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

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FDA Law Blog

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). In brief, the process begins with a request for a presubmission informal teleconference (or alternatively, a discussion as part of a pre-sNDA or pre-sBLA meeting).

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

FEBRUARY 1, 2022

To that end, FDA announced that it would take the public input it has received and form a working group to address efforts to “modernize the Orange Book, improve transparency, and provide useful information to regulated industry and the public” by…considering the comments that it has supposed to have been considering all along.

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Provider IT Consulting Manufacturing 52

FDA Law Blog

JANUARY 5, 2025

In either case, if the consumer wrongly enters their information, e.g., and as a result obtains a drug that had they entered the information correctly, they would not have received, does that make the drug misbranded and the drug manufacturer responsible for distributing a misbranded drug? 105288 (Dec.

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Provider Healthcare Individual IT 59

FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. We support FDA’s general efforts to inform healthcare providers and protect patient safety.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

OCTOBER 25, 2021

In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. FDA says inspections may be necessary if a device has “critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device.” The new rule will be codified in 21 C.F.R.

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Manufacturing Government Specialization IT 52

FDA Law Blog

MARCH 31, 2022

Last week, CMS issued Manufacturer Release 116 to put flesh on the bones of the new multiple best price option, including details about the structure of VBP arrangements and the respective responsibilities of manufacturers, states, and CMS. The manufacturer will report a best price corresponding to each GNUP. See 42 C.F.R.

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Manufacturing Hospital IT Clinic 40

FDA Law Blog

DECEMBER 16, 2024

The guidance also addresses FDAs obligation to provide considerations on third party compensation, information sharing, and conflicts of interest. All proposals underwent an initial technical, clinical, commercial, and regulatory review before receiving funding and in-kind service support.

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