FDA Law

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d Regenerative Sciences, LLC , 741 F.3d

Clinic 59

Clinic Patient-Centered Asthma Patients 59

FDA Law

AUGUST 8, 2023

All of these deviations discussed in FDA inspectional observations and Warning Letters have caused serious issues for manufacturers of APIs or finished drug products. Perhaps most importantly, the guidance concludes with examples of how manufacturers would apply this framework to Nitroso compounds.

Manufacturing 74

Manufacturing Electronics Clinic Provider 74

FDA Law

MARCH 3, 2024

The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law

NOVEMBER 1, 2022

Some key points the Agency shared included the following: Your product is only as good as the process-demonstrate your manufacturing process consistently produces drug product as per your critical process parameters (CPPs). Agency often sees issues when the drug product is put on an expedited manufacturing or an expedited clinical program.

Manufacturing 59

Manufacturing Clinic Provider IT 59

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. These LDTs are performed in clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule is a long-time coming.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

FDA Law

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?

Patients 52

Patients Clinic Medical Patient-Centered 52

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. & He presented with a high smile line and desired fixed natural appearing teeth.

Patient-Centered 52

Patient-Centered Patients Manufacturing Clinic 52

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

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. The approved devices already have patient‑directed labeling that FDA has approved. What is going on here?

Manufacturing 52

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

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law

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. Gone are the days of tool type indications for this type of device.

Patient-Centered 52

Patient-Centered Healthcare Provider Manufacturing 52

CDOCS

JUNE 30, 2021

Furthermore, upon clinical examination and evaluation of radiographs, a diagnosis of recurrent decay was established on teeth #s 6 through 11.</span></p> </span></p> <p><span style="font-size:14px;">[image:Picture1.jpg]</span><br

Family 40

Family Families Patients Manufacturing 40

FDA Law

OCTOBER 25, 2021

Specifically, for 510(k)s, QSR inspections are prohibited unless FDA finds that “there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health.” FDCA § 513(f)(5). 515(d)(2)(C). 54,826, 54,832 (Oct.

Manufacturing 52

Manufacturing Specialization Government IT 52

CDOCS

APRIL 14, 2021

& But, I don&rsquo;t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> & But, more importantly to me clinically, was the improvement in radiopacity.&

IT 52

IT Patients Provider Appointment 52

GeriPal

JUNE 20, 2024

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. And we can talk about that later in terms of potential clinical implications that may have code.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

IT 64

IT Provider Manufacturing Clinic 64

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(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

SEPTEMBER 20, 2021

As such, we present these programs and initiatives roughly in order of the newest and most substantial changes to more minor. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

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.

Manufacturing 45

Manufacturing Hypertension IT Provider 45

FDA Law

OCTOBER 1, 2024

Specifically, Vanda alleges that FDA communications to certain generic competitors regarding dissolution rates, impurities, and micronization revealed Vanda’s confidential manufacturing information and caused economic injury to the company. FOOD AND DRUG ADMINISTRATION FOIA – FDA Presentation Pending 1:2023cv02325 (D.D.C.)

Government 59

Government Appointment IT Manufacturing 59

FDA Law

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).

Specialization 40

Specialization Clinic Provider IT 40

FDA Law

DECEMBER 11, 2023

FDA also does not take into account the volume of pre-submissions that laboratories will inevitably need to begin filling almost immediately after issuance of the final rule to ensure that the data they will be presenting to FDA in their premarket submissions is what the Agency will expect. 13, 2023), [link]. 15] 21 U.S.C. § 360(m)(a)(3). [16]

IT 69

IT Medical Patient-Centered Provider 69

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. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).

Lab Testing 98

Lab Testing Government IT Manufacturing 98

CDOCS

JULY 7, 2021

Having no technical nor clinical experience with the digital production of in office restorations I fabricated a crown that I glazed in Scottsdale and cemented onto my patients&rsquo; first premolar the very next Monday at my Brooklyn N. .</span></p> Primescan captured these margins quickly with incredible detail.

Manufacturing 52

Manufacturing Treatment Plan Provider Patients 52

FDA Law

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. FDA has stated that it “considers the totality of available information regarding the device, including its potential for a clinically meaningful impact and its potential benefits and risks.”

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

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.

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2022

But I do think POLST, which I conceptualize as an advance care planning tool, really sits in between those worlds of decisions that are relevant for the present versus the few future. First of all, this does feel primarily like a manufactured controversy. And it I think really highlights how that’s a very blurry line.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Further, information presented on the adverse reaction data was inconsistent with the PI.

Vaccination 64

Vaccination IT Manufacturing Screening 64

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

This influenza infection primarily presents in cattle as decreased milk production, lethargy, and decreased appetite. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. The CDC regularly sequences isolates for changes that may lead to antiviral resistance and/or increased infectivity.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

MAY 21, 2024

The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. NPRM at 44,619. Basis at 24.

Physicals 69

Physicals Medical Clinic Emergency Room 69

Tiny Physician

OCTOBER 17, 2021

Treating with sugar pills : why homeopathic principles are unscientific Arsenicum album lacks evidence from randomized controlled trials Image taken from zeenew.india.com If you take the pain to search “Arsenicum album” in PubMed, you will find hardly 3 clinical trials conducted on this medicine. References 1.

Vaccination 52

Vaccination Government IT Clinic 52

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. Healthier populations are more productive.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

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.

Medical 59

Medical Manufacturing Patient-Centered Provider 59