FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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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. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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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

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

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. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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CDOCS

JANUARY 12, 2021

It saves dentists time and money while attracting patients and adding valuable services.</p> They currently leverage inLab design software and SprintRay to create as many same-day opportunities for their patients as possible. </p> <p>Drs.

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Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended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

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

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FDA Law Blog

APRIL 2, 2024

And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides important insight for industry to see where FDA thinks it might need congressional assistance to “better support Agency efforts to protect American consumers and patients.”

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FDA Law Blog

JUNE 2, 2025

Those in the lab industry and the physicians and patients who rely upon LDTs are sure to be breathing a well-deserved sigh of relief over this development. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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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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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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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. 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. &

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Patient-Centered Patients Manufacturing Clinic 52

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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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

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.

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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

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs). FDA staff served as pilot program observers, but also met with the contractors to provide feedback.

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FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. FDA gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

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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.

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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. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

NOVEMBER 7, 2021

We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement. Last week, the U.S.

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FDA Law Blog

MARCH 6, 2024

More information about the conference can be found here. Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. For complete information on the conference, click here.

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FDA Law Blog

MARCH 31, 2024

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input.

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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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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. 21 U.S.C. §

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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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Physician's Practice

JUNE 9, 2025

a health care attorney and practice group manager with Roetzel & Andress, joins the show to break down the hidden legal risks of prescribing GLP-1 medications that physicians need to know about, from ensuring informed consent to navigating long-term safety data. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

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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

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

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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

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. On Commerce, Manufacturing and Trade of the H. While DEA has broad inspection authority under the CSA, registrants need to be aware of the scope and limits of such inspections and be proactive in preparing for and managing inspections. Background.

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FDA Law Blog

FEBRUARY 1, 2022

And we were even more excited when that release was followed closely by an FDA Report on the comments submitted to FDA in 2020 and 2021 on the listing of patent information in the Orange Book. Several comments just wanted more information included in the Orange Book about both the patents and the drug products themselves.

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FDA Law Blog

APRIL 14, 2021

Ask and ye shall receive, if yer requests are vocal and repeated, and ye are patient, and willing to accept less than ye ask for. For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities. business days,” the same deadline set for responding to a Form 483.

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FDA Law Blog

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

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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. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

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FDA Law Blog

OCTOBER 2, 2024

As both these categories of changes are currently permitted via a PMA supplement, and the goal of FDORA is to provide an alternative to the need for such supplements, we would expect major changes and modifications to intended use to be permissible via a PCCP as long as the device remains safe and effective without any change.

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