FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Thus, the current reality of gene therapy products presents a conundrum to FDA: If you have an efficacious one-time treatment, how long do you wait to see if the treatment stops working or stops working as well, while patients receive very real benefits in the interim? That brings us to the product’s approval.

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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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Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so. percent on a dry weight basis. ”

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Drug Target Review

AUGUST 7, 2024

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. We will then present an effective strategy to address FDA’s AI request in a timely manner. By Philip Won & Adrienne R. But that is only the beginning.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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The Premier Consulting Blog

OCTOBER 11, 2022

During its first meeting with the FDA, the sponsor: Presented data by subject to the FDA in order to underscore changes over time within an individual patient. The agency requested that data be further standardized and presented by primary functional endpoint. The FDA also granted a second meeting for review.

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Agency IQ

NOVEMBER 20, 2023

A 2017 European Commission report ( EMA presentation ) highlighted various areas for improvement of product information (e.g., readability of package leaflet, patient engagement). The summary of Product Characteristics (SmPC) and the Package Leaflet (PL) are the main target for digitalization.

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Agency IQ

JULY 12, 2024

EPA grants petition on PFAS in fluorinated containers Following a loss at the Fifth Circuit, the EPA has a new plan to regulate PFAS in fluorinated plastic containers: traditional Toxic Substances Control Act Section 6 rulemaking. On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA.

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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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PPD

SEPTEMBER 6, 2023

Through rebadging, sponsors can maintain continuity on key development programs while avoiding costly severance packages and payouts. For many employees, the rebadging transition presents minimal disruption as they resume the same tasks on familiar projects. Using an FSP model in clinical research benefits employees, as well.

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Agency IQ

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles 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 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. If passed, the law would go into effect in January 2025.

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Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Now the agency will never imply that an agent does not present cancer risk, only that it either is a carcinogen or is simply not classifiable as one with the present level of evidence.

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Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.

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Advarra

JUNE 28, 2022

There are a myriad of regulations coming into play during the drug development process. Because of this, the FDA understands sponsors may need help making sense of regulations. Conversely, failing to present the information concisely is a major flaw. Failure to Have a Pre-Investigational New Drug (IND) Meeting.

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Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance 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. how to use and report (Q)SARs?”)

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Vial

MARCH 26, 2024

Samarendra Mohanty: The viral package gene therapy has been shown to target well in ophthalmic conditions, but is known to evoke inflammation primarily due to the viral capsid. How does this address the genetic variations present in these conditions? There is also a limit to the size of the transgene that AAV vector can package.

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Agency IQ

NOVEMBER 27, 2023

In relation to the presentation of information on side effects, contraindications and effectiveness, the requirements clarify that “side effects and contraindications” includes side effects, warnings and precautions, as well as any relevant information under headings such as cautions, special considerations and important notes.

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Agency IQ

SEPTEMBER 29, 2023

The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.

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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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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA regulations, at 21 C.F.R. The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. patients in harm’s way.” FDA responded in late July, denying Vanda’s petitions.

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Agency IQ

MARCH 15, 2024

The unprecedented volume of comments received during last year’s public consultation means EU regulators have had to resort to exceptional measures in the REACH restriction procedure as they seek to maintain transparency, objectivity and a high level of quality.

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The Premier Consulting Blog

JULY 31, 2024

Regulatory Pathway 505(b)(2) versus 505(b)(1) In the US, novel new small molecule drug products, including some peptides, are regulated, and approved by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Federal FD&C Act”) under two key regulatory pathways: Section 505(b)(1) and Section 505(b)(2) NDAs.

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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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Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

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Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Agency IQ

JUNE 21, 2024

Likewise, some have the propensity to travel great distances via air and sea currents, presenting a collective action problem that concerns the entirety of the EU. At their November meetings, the two committees will discuss fluorinated gas applications; as well as applications related to transport and construction products.

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Agency IQ

OCTOBER 6, 2023

The EU concluded that PFAS’ propensity to travel great distances over air and sea currents presents a collective action problem best addressed at the EU level. France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027.

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

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Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Those criteria are that the device is intended to benefit patients with a disease or condition present in 12,000 or fewer people in the E.U.

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The Pharma Data

OCTOBER 14, 2020

Relative to vaccinia, horsepox has substantially decreased virulence in mice 1. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453.

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Agency IQ

AUGUST 11, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks.

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