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. the authorization list).

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Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. Copyright © 2006-2023 Pembroke Consulting, Inc.

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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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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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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Drug Channels

OCTOBER 30, 2023

Copyright © 2006-2023 Pembroke Consulting, Inc. The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@drugchannels.net). d/b/a Drug Channels Institute.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market.

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Drug Channels

SEPTEMBER 16, 2024

The Patient Support Services Congress is designed to help educate and share innovative program design, latest customer strategies and practical solutions to overcome complex access barriers, enhance program performance and deliver best-in-class patient programs amidst evolving regulations. All rights reserved.

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Drug Channels

SEPTEMBER 3, 2024

© 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. All rights reserved. This Feed is for personal non-commercial use only.

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

Part of this 'performance' has to do with adapting to the different temporal demands of the labor market—in other words, the management of sleep and wakefulness. Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p. As Crary ( 2013 , p. 2020;183-213.

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The Pharma Data

MAY 17, 2021

Gunter, MPhil, and his colleagues at the PORTAL research group provides an analysis of the effect of market exclusivity of drugs under FDA’s Unapproved Drug Initiative (UDI). The initiative was shuttered due to concerns that the price of some legacy drugs in the US market was rising while not generating new clinical data on those drugs. .

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Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Sponsors need to carefully consider how they will prove safety and efficacy in a manner sufficient to satisfy the regulators.

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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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Agency IQ

MAY 31, 2024

What we expect the EPA to do in June 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. This is what OIRA is currently reviewing.

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The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies, January 2006. Available at [link]. [2]

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Agency IQ

MAY 3, 2024

What we expect the EPA to do in May 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA new chemicals procedural regulations. TSCA risk management rules.

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Drug Channels

AUGUST 14, 2021

In such a fluid year for medication access and affordability, join influential stakeholders as they innovate on copay program design and operations, identify key trends in market access, patient affordability and the future of the drug pricing and analyze the impact of cost sharing on out of pocket costs and high deductible health plans.

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Codon

OCTOBER 13, 2024

And while the success of these foods depends on a variety of factors — such as legislation, marketing, data-driven research, taste, and cost — sure failure will come from misinformation. billion between 1995 and 2006 attempting to eradicate citrus canker alone. The citrus industry in the U.S. In 2018, for example, the U.S.

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Agency IQ

NOVEMBER 27, 2023

Its latest report serves as a powerful indicator for what EU chemical regulation is likely to resemble in the coming years should the agency receive sufficient scientific support to meet four regulatory challenges ECHA just can’t solve without further progress from the scientific community.

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Agency IQ

APRIL 19, 2024

Draft guideline modernizes EMA recommendations on quality of inhaled, nasal products The EMA has published a draft revision to its 2006 guideline on product development quality considerations for inhaled and nasal products. In 2006, the EMA published a guideline for developers regarding the pharmaceutical quality of these products.

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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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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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Agency IQ

JANUARY 12, 2024

BY WALKER LIVINGSTON, ESQ | JAN 8, 2024 9:33 PM CST TSCA and PFAS The Environmental Protection Agency (EPA) implements the Toxic Substances Control Act (TSCA), which provides the basis for much of the chemical regulation in the United States. The Inventory does not include substances that are governed by other U.S.

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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

JULY 5, 2023

BY WALKER LIVINGSTON, ESQ JUN 29, 2023 5:51 PM CDT PFAS, PBTs, and EPA regulation Per- and polyfluoroalkyl substances (PFAS) are a wide class of synthetic organic chemicals that are used across industrial and commercial products in a variety of diverse applications.

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The Pharma Data

JANUARY 18, 2021

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. Enquiries: OKYO Pharma Limited.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g., billion for pseudoephedrine.

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The Pharma Data

DECEMBER 21, 2020

The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Eur Respir J.

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Agency IQ

JUNE 28, 2024

What we expect the EPA to do in July 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. 801.26, OMB Control No. 801.26, OMB Control No. 801.26, OMB Control No.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Copyright © 2006-2022 Pembroke Consulting, Inc.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

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Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011. Gallen (HSG), Switzerland.

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