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. Generally speaking, that recognition has limits, however.

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Government Manufacturing Individual IT 98

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

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

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.

Manufacturing 59

Manufacturing Specialization Provider IT 59

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.

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FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. By John W.M. Post-market, combination products potentially face the same enforcement scrutiny as single-entity medical devices.

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Manufacturing Patient-Centered Provider Telehealth 59

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

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.

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

FDA Law

JANUARY 2, 2023

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. cGMPs and other manufacturing concerns relative to products liability.

Manufacturing 59

Manufacturing Clinic Provider IT 59

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

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

JULY 18, 2023

The report reiterated a commitment to maintain the supply chain and provides more context about how OPQ—and FDA, more generally—are approaching quality and enforcement as we continue to hurtle past the COVID-19 public health emergency (PHE). That leaves 60% that manufacture at least one application product. and South Korea.

Supply Chain 52

Supply Chain Manufacturing IT 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

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)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

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

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

CDOCS

MAY 4, 2021

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. 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. Alex: (Singing).

IT 102

IT Screening Hospital Clinic 102

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

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.

Medical 59

Medical Manufacturing Individual Provider 59

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.

Manufacturing 59

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).

Consulting 64

Consulting Manufacturing Referral IT 64

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

Like previous iterations of the bill, it would amend the FTC Act to add new Section 27, which provides, in part, that: (A) In general.—Subject In particular, provisions have been added to expressly provide for the FTC to obtain forfeiture and civil penalties in an administrative proceeding initiated by the Commission. 1) FORFEITURE.—Each

Manufacturing 59

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. 7, 2022 at 1 p.m. EST. Attendees can register here or watch the livestream here.

Supply Chain 52

Supply Chain Illness Family Families 52

FDA Law

AUGUST 21, 2023

Koblitz & Deborah L. Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” More than a few have taken far longer—literally decades.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

Healthcare 128

Healthcare IT Education Community 128

FDA Law

JANUARY 24, 2024

One component of the OSTP report is “Biotechnology and Biomanufacturing R&D to Further Supply Chain Resilience,” and it includes nine goals in three themes “intended to provide a broad vision to build supply chain resilience for the U.S. bioeconomy.” The first goal under Theme 1—Goal 1.1—is The first goal under Theme 1—Goal 1.1—is

Supply Chain 69

Supply Chain Manufacturing Government Provider 69

FDA Law

JUNE 9, 2021

FDA also cited carbinoxamine-containing products and quinine as examples of unapproved new drugs that, due to significant adverse events, were ultimately removed from the market as a result of this program. HHS withdrew FDA’s December 29, 2020 Federal Register Notice announcing OTC monograph fees only eight days after publication.

IT 52

IT Consulting Manufacturing Provider 52

FDA Law

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. 393(d)) provides that the Secretary ‘shall be responsible for executing’ the FD&C Act ‘through the [FDA] Commissioner.’

Manufacturing 40

Manufacturing Government IT Consulting 40

FDA Law

FEBRUARY 20, 2025

Perhaps anticipating a less than favorable outcome, DOJ counsel several times asked to be allowed to submit a brief on the question of the remedy in the event of an adverse ruling. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) By Allyson B.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59

FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c). See 21 C.F.R. 251.5; § 251.6(c).

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