thought leadership

SEPTEMBER 30, 2024

However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER).

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. 21 U.S.C. § 1310.06.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. What has the MDCG published recently?

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Despite these simplification efforts, key documents, like the protocol and the ICFs, still require publication.

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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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FDA Law Blog: Biosimilars

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. 6, 2023 ( DOJ Press Release ). Consent Agreement and Final Judgment ¶ 10.a.-n.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors.

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Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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ASPET

APRIL 5, 2024

PTP4A3 is thought to regulate multiple oncogenic signaling pathways, including STAT3, SRC, and ERK. Antibody microarray assays documented differences in cytokine release and intracellular phosphorylation patterns in the PTP4A3 deleted clones. Bioinformatic network analyses indicated alterations in cellular signaling nodes.

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Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). This exemption is in accordance with Article 4(1)b of the POPs Regulation.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. By Sarah Wicks & Anne K.

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. However, a producer may also choose to apply for independent compliance with the requirements.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog: Biosimilars

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.

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Agency IQ

MAY 28, 2024

BY LAURA DIANGELO, MPH A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 29, 2024

National PFAS water regulations imminent The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

APRIL 26, 2024

BY LAURA DIANGELO, MPH A final rule requiring Laboratory Developed Tests (LDTs) to be regulated as medical devices has obtained clearance from the White House’s Office of Information and Regulatory Affairs today, allowing the FDA to publish the regulation as early as this week.

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KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. What’s next?

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Perficient: Drug Development

JULY 25, 2024

Two million documents will be lost by the IRS each year if 99.9% Risk, regulation, and legal compliance , for instance, need to be near perfect. But with more scrutiny around regulations, they’ve stopped saying that. Not Perfect Enough That’s not to say we shouldn’t ever strive to be better. Of course we should! is good enough.

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The Premier Consulting Blog

FEBRUARY 29, 2024

With the implementation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the regulatory framework has undergone a major overhaul, with stricter pre-market requirements, increased notified body involvement, and a greater emphasis on clinical evidence.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. Says the Court: “It is perhaps possible that FDA did its part to give the regulated community clear guidance and that one million out of one million not only got it wrong but got it unreasonably wrong. FDA failed on each count.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Agency IQ

JUNE 28, 2024

BY AMANDA CONTI A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products. Fill out the form to read the full article.

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Agency IQ

AUGUST 23, 2024

By Scott Stephens, MPA ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

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Agency IQ

MAY 3, 2024

BY LAURA DIANGELO, MPH The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations.

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Agency IQ

MAY 28, 2024

Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.

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