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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Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Contact us today at 919-873-4437 or online to book a consultation. The post How Gut Health and Digestion Influence Cholesterol Levels appeared first on Imperial Center Family Medicine.

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My Green Doctor

MAY 3, 2025

The product manufacturers and vendors will need to be active partners as well. The precautionary principle: what is the risk of reusing disposable drops in routine ophthalmology consultations and what are the costs of reducing this risk to zero? The unity of many voices and key stakeholders will be what creates lasting impacts!

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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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FDA Law Blog

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review.

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FDA Law Blog

APRIL 22, 2024

While FDA recommended rescheduling to schedule III, we think it more likely that if DEA reschedules marijuana it would be to schedule II because the Single Convention still requires manufacturing quotas for cannabis (which are not required for schedule III substances under the CSA). Whether DEA believes the U.S.

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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

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles. By Adrienne R.

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FDA Law Blog

JANUARY 5, 2022

Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

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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

JANUARY 5, 2022

Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

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FDA Law Blog

MAY 30, 2022

Schwartz & David Chesney (DL Chesney Consulting LLC) — Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections. Farquhar & Mark I. Some companies that have been placed on the Import Alert list pending reinspections may finally find relief.

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FDA Law Blog

JUNE 28, 2023

If a device manufacturer chooses to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA, the device manufacturer includes an ASCA declaration of conformity, an ASCA Summary Test Report and a cover letter that indicates that the submission contains ASCA testing as part of their premarket submission.

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FDA Law Blog

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. By McKenzie E. Cato & Alan M. Grab-and-go” meals and alcohol are not appropriate.

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FDA Law Blog

FEBRUARY 5, 2024

She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceutical manufacturers, wholesale distributers, and pharmacies. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

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FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. We find that this information is noteworthy for manufacturers to consider. separate patient labeling). separate patient labeling).

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FDA Law Blog

DECEMBER 7, 2023

A regulatory consultant on the panel made a recommendation to FDA that it lean more heavily on Remote Interactive Evaluations (“REIs”) to help alleviate its backlog—of which HPM recently learned the Agency had only conducted 10 in the last 30 months for purposes of drug manufacturing compliance.

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FDA Law Blog

APRIL 22, 2025

The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show Cause (or OSC) from DEA. Which option is right for you is a decision that is best made after consulting with experienced counsel.

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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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FDA Law Blog

FEBRUARY 1, 2022

FDA twice reopened the comment period, including once in response to the Orange Book Transparency Act, to ensure that all commenters had the opportunity submit recommendations as to the types of patent information that should be included in or removed from the Orange Book.

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FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

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FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

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FDA Law Blog

SEPTEMBER 20, 2021

The discussion and public comments during this workshop will inform a new strategy document with actions the Agency will take during PDUFA VII to advance the utilization of innovative manufacturing technology. Notable Dates and Timelines – New MAPP published, by Dec. 31, 2022; Publish notice of the CDRP program, by Dec.

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GeriPal

MAY 5, 2022

And so often we get consulted by teams that say, “I have this older patient and they’re pretty isolated and I think they have dementia. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers. Alex: Can I tell an anecdote here? Eric: Yeah. Anecdote away. Alex: Yeah.

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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

JUNE 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. By Larry K. 21 U.S.C. §

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Physician's Weekly

JUNE 19, 2025

Claire: All of that, but the celebrity factor isn’t really what makes Cost Plus different: The company buys meds direct from manufacturers, and adds 15 percent to their wholesale cost. Dan: Another addition: Manufacturer coupons. Bea Bosco is our consulting director of operations. And he liked what he saw.

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FDA Law Blog

MARCH 31, 2025

EO 14215 requires employees of agencies, like the FTC, to consult with the USAG on interpretations of the law and removes any agency authority to advance its own legal positions without consultation. 1096 permits the FTC to unilaterally proceed without consultation with DOJ or the USAG.

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FDA Law Blog

APRIL 2, 2025

EO 14215 requires employees of agencies, like the FTC, to consult with the USAG on interpretations of the law and removes any agency authority to advance its own legal positions without consultation. 1096 permits the FTC to unilaterally proceed without consultation with DOJ or the USAG.

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FDA Law Blog

JUNE 30, 2024

Lenz brings a wealth of experience, having provided consulting to medical device and combination product manufacturers on a wide range of pre and postmarket regulatory topics. Lenz, a highly esteemed Principal Medical Device Regulatory Expert at HPM will lead the session.

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FDA Law Blog

JANUARY 8, 2023

The Act requires DEA, in consultation with HHS, to assess annually whether an adequate and uninterrupted supply, down to specific strains, exists and to establish sufficient quotas to ensure an uninterrupted supply. Cannabis Manufacturer Registration for Research. Adequate and Uninterrupted Supply of Cannabis. Application Process.

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FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” The task force facilitates communication between device manufacturers and payors.

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FDA Law Blog

AUGUST 21, 2023

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

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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? Now they’re getting psychedelic experiences, you know, and transformation in a consulting office. So I can say anything I want. I am not sticking my foot in my mouth.

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FDA Law Blog

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 Blog

JANUARY 24, 2024

That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. Advancements in synthetic biology realized through advanced technology can improve small molecule API manufacturing. The first goal under Theme 1—Goal 1.1—is

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FDA Law Blog

SEPTEMBER 16, 2022

While it is not clear what HHS will discuss in its report, the FDA/CDER Emerging Technology Program and FDA/CBER Advanced Technologies Program are collaborative programs where industry, innovators/developers, and the FDA can discuss advanced technologies, including advanced manufacturing.

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