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 ).

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FDA Law Blog

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Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended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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Manufacturing Provider Patients IT 52

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.

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Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

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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FDA Law Blog

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. is it the lab itself, the healthcare provider, or the patient?).

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FDA Law Blog

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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Manufacturing Clinic Screening Healthcare 59

CDOCS

JUNE 30, 2021

Specifically, the patient stated he wanted younger-looking teeth and was tired of having the composites replaced every few years, and therefore desired an esthetic and lasting solution. Additionally, it was decided to add more incisal embrasures, as the patient was unhappy with the flat, worn down look of his natural teeth.</span></p>

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FDA Law Blog

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. HP&M is proud to have our professionals participating in these important events.

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Management Manufacturing Government Specialization 59

FDA Law Blog

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).

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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. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

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CDOCS

APRIL 14, 2021

& Although the Redcam may have left a lot to be desired, my patients and I loved it.& & 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> Preoperative condition.</span></em></p>

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CDOCS

SEPTEMBER 29, 2021

<p><span style="font-size:12px;"><em>Mike Skramstad, DDS</em></span><br /> <em>Sponsored by Dentsply Sirona</em></p> <p><span style="font-size:14px;">This patient presented with a RCT tooth that previously had a PFM crown.&

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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. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

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FDA Law Blog

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.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

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

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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FDA Law Blog

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)

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FDA Law Blog

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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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

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.”

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FDA Law Blog

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.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JANUARY 26, 2022

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate. Creating TV commercials ain’t cheap nor is the air time for them.

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FDA Law Blog

MARCH 20, 2022

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. It is critical for firms in a product distribution chain to be “recall ready.””.

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Electronics Manufacturing Provider IT 40

FDA Law Blog

JUNE 7, 2023

According to their defense, CMS had not made clear that they had to discount their reimbursement claims to the same degree that they discounted prices to patients. Borrowing from a scienter standard set in the Fair Credit Reporting Act (FCRA), the chain pharmacies asserted that was exactly what they were doing.

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Government Patient-Centered Manufacturing IT 40

FDA Law Blog

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. Certain points are indisputable.

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IT Medical Patient-Centered Provider 69

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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Specialization Clinic Provider IT 40

FDA Law Blog

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.

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FDA Law Blog

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

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. My first experience with CEREC was creating a single unit crown during a CEREC ACCEPT program.

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Manufacturing Treatment Plan Provider Patients 52

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 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

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. To address these barriers, FDA promotes the development of impactful devices that can enhance accessibility for patient populations with limited or no available options.

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Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 24, 2022

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. 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.

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Illness IT Healthcare Patient-Centered 72

FDA Law Blog

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.

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Manufacturing Consulting Healthcare Professional Vaccination 40

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.

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FDA Law Blog

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.

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Physicals Medical Clinic Emergency Room 69

Tiny Physician

OCTOBER 17, 2021

One trial was conducted to find whether it is effective in fever on children post-DPT vaccination, another one on neonatal calf diarrhea (an animal study), and the last one on its effect on patients with Arsenic toxicity (4). However, there is no clinical trial on its effect on COVID 19 infection or its complications.

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