FDA Law

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.

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FDA Law

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. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

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FDA Law

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R. FDA), and to generate data in a format that would streamline FDAs review.

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FDA Law

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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FDA Law

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

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FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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FDA Law

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. Almost all recalls are conducted on a voluntary basis by the manufacturer.

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FDA Law

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

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GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. One thing we’ve looked at a little bit, but it has not been well studied is the accumulation of ototoxic medications. Five big manufacturers. Eric: Yeah.

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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. §

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Physician's Weekly

JUNE 19, 2025

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. They started trying out different medications and dosages. This is gonna be a process.

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FDA Law

JUNE 30, 2024

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape. To register visit the official conference website, here. Meet the Expert: Adrienne R.

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FDA Law

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

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FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

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GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? What made this trial, I would say, unique, is that you have a palliative care physician and nurse following people with medication tapering in order to be dosed. Like all of.

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FDA Law

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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FDA Law

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. Updating the list, DEA consulted law enforcement officials, forensic laboratory authorities, intelligence groups, drug signature and profiling programs, and international organizations.

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FDA Law

JANUARY 24, 2024

One component of the OSTP report is “Biotechnology and Biomanufacturing R&D to Further Supply Chain Resilience,” and it includes nine goals in three themes “intended to provide a broad vision to build supply chain resilience for the U.S. bioeconomy.” The first goal under Theme 1—Goal 1.1—is And so in November 2023 in St.

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FDA Law

JUNE 9, 2021

There, HHS threw FDA under the bus, issuing a statement that the imposition of user fees on hand sanitizer manufacturers “was not cleared by HHS leadership, who only learned of it through media reports” and that the HHS Secretary “would never have authorized such an action.”

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FDA Law

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. Glove manufacturers affected by the exemption should beware of the likely reinstatement of the 510(k) requirements.

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FDA Law

FEBRUARY 20, 2025

In contrast, AMP and ACLA both asserted that the rule would harm medical care. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) The LDT Rule itself provides no operational guidance, but only a definition.

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