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

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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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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FDA Law Blog: Biosimilars

MARCH 15, 2023

s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. Hyman, Phelps & McNamara, P.C.’s

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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

DECEMBER 1, 2023

What we expect European regulators to do in December 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

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.

Regulations 40

Regulations Clinical Trials Production Trials 40

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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Drug Channels

OCTOBER 23, 2023

Informa Connect’s Trade and Channel Strategies Hybrid Event | December 11-13, 2023 DoubleTree By Hilton | Philadelphia, PA Exclusive Offer–Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. Why should you attend this pivotal event? Trade and Channel Strategies is back and we have a lot to talk about!

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FDA Law Blog: Biosimilars

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. 1] However, the focus of CLIA requirements is on laboratory processes, not specific assays.

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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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FDA Law Blog: Biosimilars

JANUARY 24, 2024

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. For nearly 20 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA law and regulation. Join our co-chairs Kurt R.

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FDA Law Blog: Biosimilars

JULY 22, 2024

Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” s John W.M. s John W.M.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

The event is set to take place from March 4-6, 2024, in San Francisco, California. Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law.

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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

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide. Hyman, Phelps & McNamara, P.C. (HP&M),

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. To obtain a copy of the conference brochure and to register for the event, please visit ACI’s website – here.

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FDA Law Blog: Biosimilars

JULY 30, 2024

By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Additionally, there will be smaller touches that often go overlooked like podium branding, event signage, publication cover art and more. But FDLI is also thinking beyond logos and websites—2024 will be filled with events to mark FDLI’s 75th anniversary.

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Compliance Regulations FDA Production 59

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M. 21 CFR 820.20

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

830(e)(1)(B)(i). “Regulated sellers” (retail distributors including pharmacies, grocery stores, general merchandise stores and mobile vendors) selling “scheduled listed chemical products” (“SCLPs”) (products containing ephedrine, PSE and phenylpropanolamine that may be marketed in the U.S. 2, 2020 ( DOJ Press Release ). 21 U.S.C. §

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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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. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT 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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Marketing Regulations Biosimilars Drugs 40

The Pharma Data

MAY 18, 2021

Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. You should not place undue reliance on these statements.

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FDA Law Blog: Biosimilars

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Modifications that are not consistent with the authorized PCCP, however, must be evaluated in accordance with the traditional regulatory process described in applicable regulations and guidances referenced above. See 21 CFR 807.81(a)(3)

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The Pharma Data

DECEMBER 3, 2021

Zuranolone 50 mg was generally well-tolerated with an overall adverse event profile consistent with data reported earlier and 6.5% of patients discontinuing study drug due to adverse events. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.

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The Pharma Data

MARCH 5, 2021

To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines.

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The Pharma Data

OCTOBER 27, 2020

Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The remaining 19% would be furloughed.

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The Pharma Data

JUNE 1, 2022

In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Food & Drug Administration.

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