FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.

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biobide

AUGUST 18, 2023

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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H1 Blog

NOVEMBER 21, 2023

The life sciences industry, characterized by stringent regulations, vast data sets, and the critical nature of its decisions, is increasingly turning to Artificial Intelligence (AI) for solutions. However, before integrating an AI product into a life sciences workflow , it is crucial to evaluate its effectiveness and reliability rigorously.

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thought leadership

NOVEMBER 14, 2023

If implemented, this rule would result in LDTs generally falling under similar enforcement regulations as other in vitro diagnostic (IVD) products, a significant change from existing policy. Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs).

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Agency IQ

OCTOBER 20, 2023

PFAS are found in drinking water, consumer products such as textiles, cookware, and personal care products, and firefighting foam. In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health.

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PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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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).

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Perficient: Drug Development

MARCH 11, 2024

The shift from a project to a product mindset is particularly relevant for health insurers and healthcare providers as they aim to enhance their agility, responsiveness, and consumer-centric focus. Shifting to a product mindset enables HCOs to better understand patient and member needs.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. The conference, held in Washington, D.C., April 4th and 5th, is an in-person and virtual event.

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Cytel

MAY 7, 2024

In 2000, the EU established its Orphan Drug Regulation, offering a ten-year market exclusivity from similar products within the same indication, to encourage the development of drugs for conditions affecting not more than five in 10,000 citizens.

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Advarra

JULY 26, 2022

In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements. The 2018 Farm Bill.

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The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. The performance characteristics of this product have not been established.”

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Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As defined in statute, the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.”

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FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Covalent Modifiers

MARCH 1, 2024

CHANG Science 2023 382, 6670 DOI: 10.1126/science.abp9201 INTRODUCTION One-carbon metabolism manages cellular carbon pools by detoxifying highly reactive carbon species, such as aldehydes, and diverting their carbon toward the biosynthesis of useful products, including amino acids and nucleotides.

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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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Agency IQ

NOVEMBER 10, 2023

The FDA announced it intends to delay enforcement of cosmetic facility registration and cosmetic product listing requirements to July 1, 2024, from the current deadline of December 29, 2023 as required by Modernization of Cosmetics Regulation Act or MoCRA. Fill out the form to read the full article.

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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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Broad Institute

AUGUST 7, 2023

A surprising new role for a major immune regulator By Tom Ulrich August 7, 2023 Breadcrumb Home A surprising new role for a major immune regulator By Anne Trafton, MIT News August 7, 2023 Credit: RCSB Protein Data Bank A model of the human STING protein.

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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

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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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Chemical Biology and Drug Design

JANUARY 5, 2024

The levels of adenosine triphosphate (ATP)/adenosine diphosphate (ADP) ratio, lactate production and glucose consumption were detected to evaluate glycolysis. Moreover, matrine also could regulate PDK1 expression to suppress AML progression. Besides, matrine modulated miR-495-3p/miR-543/PDK1 axis to inhibit the Wnt/β-catenin pathway.

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thought leadership

SEPTEMBER 20, 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category. A peptide is any polymer with 40 or fewer amino acids.

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Olympian Clinical Research

FEBRUARY 13, 2024

When it comes to maintaining healthy, vibrant skin, the choice of skincare products plays a pivotal role. At Academic Alliance in Dermatology, we understand the importance of using products that not only care for your skin on the surface but also work effectively at a cellular level.

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Fierce BioTech

MAY 31, 2024

Listing Image QuartzListingLogo_250x190_sware.png Listing Introduction As AI capabilities push into GxP regulated business functions, how can Quality and IT teams partner to ensure they are properly controlled? Click here to login.

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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

Why comprehensive state-level bans on PFAS in products are faltering Despite a wide array of bans on per- and polyfluoroalkyl substances (PFAS) progressing through state legislatures, even the planning around the implementation of some of these efforts has led the legislatures to amend or abandon the bans.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement.

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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

JUNE 17, 2024

BY SCOTT STEPHENS, MPA 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. Fill out the form to read the full article.

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SCIENMAG: Medicine & Health

AUGUST 16, 2023

Phytoplankton determine how much life the ocean is able to support and play a role in controlling atmospheric carbon dioxide concentrations, thereby regulating our climate.

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Drugs.com

AUGUST 8, 2024

8, 2024 -- That vape pen might contain something even worse than nicotine, new research warns.Tobacco companies may be trying to duck federal restrictions on vaping products by replacing nicotine with “nicotine analogs” -- related che. THURSDAY, Aug.

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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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Drug Target Review

MARCH 6, 2024

We optimised the profile of the chemical series by simultaneously addressing multiple critical endpoints and balancing requirements in terms of potency, safety, CNS penetration and ADME profile (bioavailability, half-life, metabolism etc), aiming to solve a complex target product profile and to overcome these design challenges.

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