FDA Law Blog

FEBRUARY 13, 2025

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

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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

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. See 42 U.S.C. 1320a-7b(b). The Alert described several factors that could potentially violate the antikickback statute.

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The Medical Futurist

JUNE 21, 2025

Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device. Are 3D printed and digital contact lenses the future? Yet, it might be a reality soon. A truly disruptive innovation: smart, cheap and potentially life-changing!

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The Medical Futurist

JUNE 21, 2025

Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work.

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FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.

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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).

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FDA Law Blog

MAY 4, 2025

Both chemicals are used in the illicit manufacturer of fentanyl. 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. from China and transshipped to Eagle Pass for export to Mexico for manufacturing fentanyl.

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FDA Law Blog

MARCH 9, 2025

As such, we can offer our readers a special 10% discount. John Claud will speak at a session titled Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets, where he will explore two areas of global focus for the cosmetics industry: Latin America and China.

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Manufacturing Specialization Provider Management 59

FDA Law Blog

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Always mix formula as directed by the manufacturer. If your child is older than 6 months of age and is usually on regular formula (not a specialty product for allergies or other special health needs), this may be an option. Always follow label instructions or those given to you by your pediatrician. Can I make my own baby formula?

Supply Chain 52

Supply Chain Specialization IT Family Medicine 52

Minnesota Academy of Family Physicians

MARCH 27, 2025

The Minnesota Council of Health Plans (MCHP) raised concerns, as the bill enacts new regulations on health plans, and they contend they have little control over pricing set by drug manufacturers. This will trigger a special election in District 6. The bill was laid over for possible inclusion in a future omnibus bill.

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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

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

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. Key Performance Indicators.

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FDA Law Blog

MAY 27, 2024

She also specializes in medical device software and digital health. She was an outstanding lawyer before, and her in-house experience will provide even greater breadth and depth of expertise to medical device manufacturers,” notes Jeffrey Gibbs, HPM Director.

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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.

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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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Management Manufacturing Specialization IT 52

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. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. While at FDA, Ms. During her FDA tenure, Ms.

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Engineering Manufacturing Specialization Management 59

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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Manufacturing Government Specialization IT 52

Imperial Center Family Medicine

MAY 26, 2025

Save this tropical oil for special occasions versus everyday cooking when managing cholesterol through diet. Partially Hydrogenated Oil To give processed foods a longer shelf life, manufacturers often add partially hydrogenated oil, a source of trans fats that are much worse for cholesterol levels than saturated fats.

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FDA Law Blog

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. We can offer our readers a special discount for the event. The discount code is S10-896-896L24.S. Details on the conference can be found here.

Management 59

Management Manufacturing Government Specialization 59

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.

Management 40

Management Manufacturing Specialization IT 40

FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

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Provider Manufacturing IT Medical 64

FDA Law Blog

SEPTEMBER 30, 2022

The controversy over the FCA’s intent standard where the applicable statute or regulation is ambiguous has special relevance when the FCA is used to target inaccurate government price calculations. The AMP, best price, and ASP statute and regulations are complex and full of gaps and ambiguities.

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Insurance Manufacturing Government Specialization 40

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

JUNE 7, 2023

Doing business with the federal government comes with numerous restrictions and special provisions in exchange for the benefit of having access to Federal reimbursements.

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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. If the registrant has a manufacturing or import quota, the investigators may ensure the registrant has not exceeded their established quota.

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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. If the registrant has a manufacturing or import quota, the investigators may ensure the registrant has not exceeded their established quota.

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Management Consulting Provider Physicals 40

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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FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. Municipal Regulation § 8305.11.

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

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FDA Law Blog

MAY 11, 2023

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.” Whether the Court takes up Teva v. GSK is still up in the air.

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