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. The speaker program should occur in a venue that is conducive to the informational communication.

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FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

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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. If a submitter believes that certain testing described in the draft guidance does not apply to their device, they should provide a rationale in the 510(k) submission.

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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

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). 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.

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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. What Are Your Options When You Receive an Order to Show Cause?

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FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Registrants may withhold consent or, if given, can withdraw consent at any time.

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FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. Registrants may withhold consent or, if given, can withdraw consent at any time.

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FDA Law Blog

MARCH 20, 2022

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. The Guidance emphasizes that firms need to be “recall ready.”

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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. And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. Five big manufacturers. Eric: Great.

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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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Physician's Weekly

JUNE 19, 2025

This is the kind of information we all need, all deserve. Because when Bob calls to check on the prior authorization– PA for short– Well, here’s how he says the conversation went… Bob: ‘Yes, we got the PA information. Dan: Another addition: Manufacturer coupons. And maybe we can put a little dent in that.

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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. 21 U.S.C. § 21 U.S.C. §

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FDA Law Blog

JANUARY 8, 2023

The report must also discuss the barriers associated with conducting research with cannabis and CBD in states that have legalized their use, how barriers might be overcome and whether public-private partnerships or federal-state partnerships can or should provide researchers with additional cannabis and CBD strains. 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

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.

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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. Eric 24:59 Have to release any embargoed information with us.

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FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 23,711 (June 4, 2025).

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FDA Law Blog

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 Blog

FEBRUARY 20, 2025

That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. The last time CDRH was significantly resource constrained (i.e.,

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