FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. 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.

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Cytel

OCTOBER 23, 2023

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the two main divisions of the FDA responsible for regulating drugs and biological products, as well as combinations of drugs and biological products.

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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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KIF1A

OCTOBER 21, 2023

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. From Gabrych et al.

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Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.

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thought leadership

MARCH 26, 2024

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation 1 to revise many of the currently applicable Regulations.

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Perficient: Drug Development

JUNE 4, 2024

Compliance : For organizations operating in regulated industries or regions with strict compliance requirements, self-hosted runners offer greater control and visibility over where code is executed and how data is handled, facilitating compliance efforts. zip", "$PWD") Configure the runner using the below command.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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FDA Law Blog: Biosimilars

JULY 22, 2024

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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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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

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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DrugBank

OCTOBER 30, 2024

That’s why DrugBank is making it easier than ever to access our data packages through Snowflake Marketplace, allowing you to explore and trial our offerings seamlessly to support your work and enhance decision-making.

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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

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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The Pharma Data

JULY 11, 2021

In a previously-published Phase 2 study evaluating patients with UC, mirikizumab down-regulated several gene transcripts associated with inflamed mucosa and up-regulated gene transcripts correlated with healthy mucosa and markers of functional healing after 12 weeks, as defined by clinical disease indices of endoscopy and histology.

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biobide

NOVEMBER 20, 2023

Additional contributing factors include an increased awareness of fashion trends, innovations in the areas of hair coloring and skincare product formulations, and developments in the area of packaging. Such concerns have led to strict regulations regarding the formulation of cosmetic products.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). PMA or 510(k)) is required.

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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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Agency IQ

AUGUST 25, 2023

As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. PFAS regulation in the E.U. Two high-profile initiatives to regulate PFAS in the E.U. are currently underway. years for all consumer products covered by the ban.

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Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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Agency IQ

AUGUST 30, 2024

By Scott Stephens, MPA In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation.

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Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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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

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new 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

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

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Drug Target Review

JULY 7, 2023

The epigenome (meaning ‘above the genome’) is a system of reversible marks regulating how the DNA is read, translated and used. The molecular machinery of the epigenetic system can selectively package specific regions of DNA away, making them inaccessible and less active. We are on the precipice of a new era in genetic medicine.

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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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. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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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. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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The Premier Consulting Blog

MAY 4, 2023

The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. Therefore, the FDA will examine product classifications, especially for those products that have been regulated as drugs even though they may satisfy the device definition.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

JUNE 16, 2023

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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