FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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FDA Law Blog

MARCH 27, 2023

In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID). So, what is special about September 24, 2023? Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.”

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FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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CDOCS

FEBRUARY 14, 2025

</strong> now allows users to upload bridge case designs to DS Core, enabling centralized management of end-to-end manufacturing tasks. This integration ensures all necessary information is included for seamless manufacturing. .& </span></p> <p>[image:Picture4.png]</p>

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FDA Law Blog

OCTOBER 31, 2022

It seems that FDA may have validated that, even with an Excellence Appraisal above and beyond standard compliance with good manufacturing practices, there is a need for pre-market review for Class 2 devices. Despite the limitations in testing, some of the findings were noteworthy.

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FDA Law Blog

OCTOBER 2, 2024

We find it surprising that a PCCP may not be submitted with a Special 510(k), given a Special 510(k) may be used to modify an existing device where well-established methods are available to evaluate the change. FDA, Guidance for Industry, The Special 510(k) Program (2019). Draft Guidance at 4.

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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. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

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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

MARCH 6, 2024

More information about the conference can be found here. For complete information on the conference, click here. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. S for reduced registration fees.

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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FDA Law Blog

OCTOBER 25, 2021

In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. FDA says inspections may be necessary if a device has “critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device.” FDCA § 513(f)(5). 515(d)(2)(C).

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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FDA Law Blog

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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FDA Law Blog

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

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FDA Law Blog

MAY 7, 2025

Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. DEA’s notice of updates with the Special Surveillance List is attached here.

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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. §

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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

MAY 19, 2022

If FDA concludes otherwise, proceeding to market with the formula could leave the manufacturer vulnerable to regulatory action. The guidance offers an opportunity that could be of special interest to foreign manufacturers who already market infant formula in other countries and have considered entering the U.S.

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GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. 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? James 01:34 Yeah, right on.

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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. DEA published the original Special Surveillance in May 1999.

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GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. Its major goal is to try to pull together information on aging and climate change for three groups. What’s our role in changing the healthcare system, in our own healthcare system.

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” For example, TPSAC noted that FDA would need to assess the potential for contraband menthol cigarettes, which was required by the Act.

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” For example, TPSAC noted that FDA would need to assess the potential for contraband menthol cigarettes, which was required by the Act.

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FDA Law Blog

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. It is therefore surprising that nearly a month or more has passed for four of these five de novos without any information being posted. By Allyson B.

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