Animal Testing, Document and Marketing

Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

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.

Animal Testing

Animal Testing Regulations Production Compliance

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

Animal Testing

Animal Testing Regulations Production Research

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Agency IQ

NOVEMBER 27, 2023

This document can be understood as something of a dialogue between regulators and the research entities which provide them with leverageable data, as well as the methodological tools to interpret this same data’s regulatory significance. The next key area concerns the ongoing shift away from animal testing.

Animal Testing

Animal Testing Research Regulations Compliance

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Sections 5 – 9 are labeled as Part A and cover clinical evaluation considerations.

Trials

Trials Marketing Clinical Trials Regulations

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

Regulations

Regulations Animal Testing Production Marketing

Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

Agency IQ

OCTOBER 12, 2023

EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process The General Court of the European Union this week upheld the non-renewal of market authorization for chlorpyrifos-methyl used as an active substance in pesticides. It also found this approach beneficial because it reduces the need for animal testing.

Regulations

Regulations Animal Testing Government Production

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

FDA

FDA Animal Testing Engineering Regulations

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Agency IQ

JANUARY 12, 2024

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. The most recent version of the document listing the categories is from 2010.

Animal Testing

Animal Testing Regulations Production Marketing

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

MARCH 7, 2024

At the same time, Hojsik pointed to the positive impact that the 1S1A ambition should have on data sharing, thereby reducing animal testing, another objective of the Green Deal. Streamlining these processes, according to the proposal, should improve transparency and reduce administrative efforts for stakeholders.

Regulations

Regulations International Government Compliance

FDA Modernization Act 2.0: A step in the right direction

Drug Discovery World

APRIL 12, 2023

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now all be regarded as suitable alternatives to animal testing in the early phases of drug development. The limitations of animal studies are widely documented. This is essential. Am J Transl Res.

FDA

FDA Animal Testing Cell Based Assays Clinical Trials

Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Agency IQ

JANUARY 26, 2024

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

FDA

FDA Animal Testing Packaging Regulations

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics. Nonclinical studies encompass much more than just animal studies.

FDA

FDA Science Small Molecule Immune Response

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. For in-depth analysis of the CARACAL documents on the CDPC see AgencyIQ’s July 10, 2023 article. ] This proposal is long overdue, as it was initially slated for the first quarter of 2023. [

Packaging

Packaging Regulations Laboratories Animal Testing

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

Dr Megan MacBride and Dr Caroline Horizny Mitchell , Taconic, examine recent changes to animal testing in drug design. This stage is more highly regulated and consists of both preclinical testing and clinical trials. Drug discovery and development is an arduous process that can cost upwards of $2.6 million USD.

Small Molecule

Small Molecule Pharmaceutical Companies Animal Testing Pharmaceuticals

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 The Tropical Disease Priority Review Voucher (PRV) program.

FDA

FDA Packaging Science Drugs

Tort-Related Implications of Recent FDA Device Draft Guidances

Drug & Device Law

NOVEMBER 6, 2023

A “predicate device” is the already marketed medical device against which the §510(k) “substantial equivalence” comparison is made. is important for the device to be used safely.” For certain implants, information regarding raw materials and critical aspects of manufacturing and processing steps. . . of the final, finished device.”

FDA

FDA Animal Testing Licensing Licensing

Drug Discovery Digest

Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Analysis Chemical Thank You Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative

Trending Sources

Analysis Chemical Thank You ECHA issues research wish list to aid in its regulatory endeavors

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

FDA Modernization Act 2.0: A step in the right direction

Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Accelerating NDA filing through faster carcinogenicity assessment

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Tort-Related Implications of Recent FDA Device Draft Guidances

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