FDA Law

JULY 20, 2021

We previously reported on events that resulted in this rule. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). The final rule was published on July 14, 2021. The rule does not set a new standard for MUSA claims.

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IT Electronics Manufacturing Individual 76

FDA Law

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.

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Government Manufacturing Individual IT 98

FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

CDOCS

JANUARY 12, 2021

By leveraging existing technologies such as CEREC inLab, 3D printing enables better responsiveness to patient needs, significantly reduces manufacturing times, and opens up new treatment options. <p>CEREC design tools are widely used in many dental practices.</p> </p> <p>Drs. </p>

Manufacturing 52

Manufacturing Utilities Patients IT 52

FDA Law

FEBRUARY 9, 2024

Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study. The sponsor should be able to describe the DHT design and technological characteristics, data output provided, and how the DHT measures the event of interest. By Adrienne R.

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Clinic Manufacturing Provider Electronics 105

FDA Law

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. You can access the conference brochure and sign up for the event here. And it is exactly that! As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

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Manufacturing Specialization Provider IT 59

FDA Law

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP.

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Manufacturing Electronics Provider Management 64

FDA Law

JULY 7, 2022

By Riëtte van Laack — On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act ( S.4348). While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics.

Manufacturing 52

Manufacturing Education IT 52

FDA Law

JANUARY 5, 2023

But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. FDA has shown a willingness to intervene in this space.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017.

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Supply Chain Electronics Manufacturing Provider 52

FDA Law

AUGUST 14, 2023

Other interesting datapoints from her presentation: For the period from FY2000 to May of 2023, the percentages of drug manufacturing inspections with OAI classifications was lower in China (about 5% of inspections) than in the United States (8%). OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance.

Manufacturing 52

Manufacturing Provider IT Medical 52

FDA Law

JULY 18, 2023

Geography of Manufacturing Sites OPQ reports that as of October 2022, CDER’s manufacturing site catalog listed 4,814 facilities, a 12% increase over 2018. That leaves 60% that manufacture at least one application product. Four specific kinds of events comprised over a third of the 900+ recalls. and South Korea.

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Supply Chain Manufacturing IT Provider 52

FDA Law

FEBRUARY 26, 2025

The answer to that is still no, the current state of world and governmental events notwithstanding. Trusting suppliers is still fundamental to any drug or device manufacturer. Finally, effective compliance and quality communication is not a one-off event. Dialogue is also key. HPM Counsel John W.M.

Supply Chain 66

Supply Chain Management Manufacturing IT 66

FDA Law

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. If held in a third-party venue, the venue “should not be extravagant or the main attraction of the event” (e.g.,

Specialization 52

Specialization Manufacturing Education Provider 52

FDA Law

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

Manufacturing 52

Manufacturing IT Relationship Medical 52

FDA Law

JANUARY 2, 2023

cGMPs and other manufacturing concerns relative to products liability. Proactive adverse events monitoring and signal detection. This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R. The role of the Hatch-Waxman Act in the patenting of drugs and biologics.

Manufacturing 59

Manufacturing Clinic Provider IT 59

FDA Law

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development. The latest iteration, version 5.0, released in April 2024, marks the first update since 2020.

Manufacturing 52

Manufacturing Healthcare Education Utilities 52

FDA Law

DECEMBER 21, 2021

is pleased to announce that Adrienne Lenz will be speaking on Deciphering New and Proposed Regulatory Guidances For Medical Devices and Diagnostics at the Q1 Productions 4th Annual Life Science Regulatory Intelligence Virtual Event being held January 24-25, 2022. You can access conference information and register for the event here.

Medical 40

Medical Manufacturing IT 40

FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. the wholesale distributor, repackager, relabeler). Draft Guidance III.B.2(d)

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Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: (Singing).

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IT Screening Hospital Clinic 102

FDA Law

OCTOBER 10, 2023

We find that this information is noteworthy for manufacturers to consider. FDA encourages manufacturers to submit a pre-submission to discuss the animal study protocol with the Agency before submitting a 510(k) application.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

FDA Law

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

Clinic 59

Clinic Provider IT Electronics 59

FDA Law

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

Manufacturing 45

Manufacturing Individual Government Illness 45

CDOCS

MAY 4, 2021

The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings. I requested a core file which was downloaded into CEREC before the Atlantis abutment was delivered to my office and used for the design and manufacture of the e.max crowns.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

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. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Physicals Provider Electronics 64

FDA Law

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

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Medical Manufacturing Individual Provider 59

FDA Law

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.

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Manufacturing Specialization IT 75

FDA Law

JUNE 24, 2021

“Remanufacturing” is also included in the definition of “manufacturer” in the regulations. In contrast, a device servicer is not a device manufacturer and, therefore, need not comply with the QSR.

Manufacturing 52

Manufacturing Medical Provider IT 52

FDA Law

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Manufacturing Clinic Medical IT 59

FDA Law

MARCH 31, 2025

A) IN GENERAL.Each party that violates or assists in the violation of paragraph (1) shall forfeit and pay to the United States a civil penalty sufficient to deter violations of paragraph (1), but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of paragraph (1).

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Consulting Manufacturing Referral IT 64

FDA Law

JUNE 12, 2022

The DOJ contends that a failure to report adverse events as required under FDA’s regulations could mask problems that would have led FDA “to institute or require a product recall.”. By Jeffrey K. Shapiro & Anne K. Walsh — Legal doctrines can be like parrots. Sometimes it is hard to know if they are dead or just resting. So is fraud?on?the?FDA

IT 52

IT Manufacturing Government 52

FDA Law

APRIL 2, 2025

A) IN GENERAL.Each party that violates or assists in the violation of paragraph (1) shall forfeit and pay to the United States a civil penalty sufficient to deter violations of paragraph (1), but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of paragraph (1).

Consulting 59

Consulting Manufacturing Referral IT 59

FDA Law

AUGUST 29, 2024

Each party that violates or assists in the violation of this section shall forfeit and pay to the United States a civil penalty sufficient to deter violations of this section, but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of this section.

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Manufacturing Provider IT 59

FDA Law

NOVEMBER 22, 2022

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S.

Supply Chain 52

Supply Chain Illness Family Families 52

FDA Law

MAY 15, 2025

Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. The agency, he noted, isnt a passive inbox for industry petitions.

Manufacturing 59

Manufacturing Vaccination Illness IT 59

FDA Law

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling. complex public health issues within 100(!) The Assessment does not focus solely on safety.

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Chronic Disease Government Chronic Condition Clinic 59

FDA Law

AUGUST 21, 2023

FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. Koblitz & Deborah L. More than a few have taken far longer—literally decades.

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