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Dr. Mark Arnold, Ph.D., FAAPS

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Bioanalytical Solution Integration

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ICH posts consolidated E6(R3): Good Clinical Practice Guideline with approved Annex 2

Posted By Mark Arnold 07-10-2026 08:46
Found In Egroup: Translational and Clinical Science Community \ view thread
ICH just posted a consolidated E6(R3): Good Clinical Practice Guideline combining the Principles document, Annex 1 and the recently adopted Annex 2. At 91 pages it will take several reads to understand all of it, but Annex 2 is loaded with information, as is the Essential Records Table in Appendix C ...

FDA technical specifications guidance on "Submitting Next-Generation Sequencing Data to the Division of Antivirals"

Posted By Mark Arnold 07-06-2026 18:05
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA released a final guidance - one with technical specifications on "Submitting Next-Generation Sequencing Data to the Division of Antivirals". The Agency notes that it does its own analysis and why: "The Division performs independent analyses of all NGS data associated with antiviral drugs, including ...

FDA releases a guidance revision draft entitled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products"

Posted By Mark Arnold 06-29-2026 10:29
Found In Egroup: RegulatoryScience Community \ view thread
This is Revision 1 to the May 1998 guidance "Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products", and is applicable to new drug applications (NDAs), biologics license applications (BLAs), or supplements to NDAs or BLAs that require the demonstration of substantial evidence ...

FDA releases a guidance revision draft entitled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products"

Posted By Mark Arnold 06-29-2026 10:28
Found In Egroup: Translational and Clinical Science Community \ view thread
This is Revision 1 to the May 1998 guidance "Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products", and is applicable to new drug applications (NDAs), biologics license applications (BLAs), or supplements to NDAs or BLAs that require the demonstration of substantial evidence ...

FDA posts draft guidance "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials"

Posted By Mark Arnold 06-25-2026 16:34
Found In Egroup: Translational and Clinical Science Community \ view thread
The Agency frames this 10-page guidance in the Introduction as "The focus of this guidance is on drugs for which the MABEL approach is recommended to guide starting doses for FIH trials. This can, but does not necessarily, include drugs that cause T-cell activation and subsequent cytokine release. ...

EU Commission "Roadmap towards phasing out animal testing for chemical safety assessments"

Posted By Mark Arnold 06-25-2026 09:23
Found In Egroup: Discovery and Preclinical Research Community \ view thread
For those following the NAM discussions in the US and EU, the EU has just advanced its position and plan in this Roadmap. The Objectives of the Roadmap section starts with a very clear set of statements on its intent: "This roadmap sets out the clear objective and concrete steps needed to transition ...

EU Commission "Roadmap towards phasing out animal testing for chemical safety assessments"

Posted By Mark Arnold 06-25-2026 09:21
Found In Egroup: Translational and Clinical Science Community \ view thread
For those following the NAM discussions in the US and EU, the EU has just advanced its position and plan in this Roadmap. The "Objectives of the Roadmap" section starts with a very clear set of statements on its intent: "This roadmap sets out the clear objective and concrete steps needed to transition ...

FDA posted a revised draft guidance "Master Protocols for Drug and Biological Product Development".

Posted By Mark Arnold 06-23-2026 17:31
Found In Egroup: Translational and Clinical Science Community \ view thread
This draft reflects changes based on comments submitted to the December 21, 2023 draft guidance that is for clinical trials operating under a master protocol. The introduction notes three examples of trial operating under a master protocol: umbrella, basket and platform. The Introduction also notes: ...

FDA posted a revised draft guidance "Master Protocols for Drug and Biological Product Development".

Posted By Mark Arnold 06-23-2026 17:29
Found In Egroup: RegulatoryScience Community \ view thread
This draft reflects changes based on comments submitted to the December 21, 2023 draft guidance that is for clinical trials operating under a master protocol. The introduction notes three examples of trial operating under a master protocol: umbrella, basket and platform. The Introduction also notes: ...

FDA final guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug"

Posted By Mark Arnold 06-18-2026 13:07
Found In Egroup: RegulatoryScience Community \ view thread
The FDA just dropped a final guidance entitled "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug" that will be of interest to the immunogenicity and pharmacokinetics community, as well as those responsible for compiling the data sets for filings. ...

FDA final guidance "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug"

Posted By Mark Arnold 06-18-2026 13:04
Found In Egroup: Translational and Clinical Science Community \ view thread
The FDA just dropped a final guidance entitled "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug" that will be of interest to the immunogenicity and pharmacokinetics community, as well as those responsible for compiling the data sets for filings. ...

FDA workshop announcement: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology

Posted By Mark Arnold 06-03-2026 09:42
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA, Health and Environmental Sciences Institute and Safety Pharmacology Society announced a Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology Date: July 28, 2026 Time: 9:00 a.m. - 4:00 p.m. ET Location: Attend In Person or Online Virtual: Teams In Person: FDA ...

FDA draft guidance on "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing"

Posted By Mark Arnold 06-02-2026 14:29
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
The FDA released today (2Jun26) this draft guidance: "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing" This 23-page draft guidance covers how to use prior knowledge to support chemistry, manufacturing, and controls (CMC); nonclinical; and clinical ...

New FDA draft guidance: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products

Posted By Mark Arnold 06-01-2026 17:42
Found In Egroup: Translational and Clinical Science Community \ view thread
On Friday, May 27th, 2026, the FDA issued a new draft guidance: "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products". It is a very short guidance at just 4 pages, but aligns well with the past year's publications, announcements, and guidance on reducing ...

FDA publishes 2 final guidances related to BE studies

Posted By Mark Arnold 05-28-2026 12:33
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA published two final guidances for industry: "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" and "Statistical Approaches to Establishing Bioequivalence". From the announcement: "The guidance for industry entitled "Bioequivalence Studies with Pharmacokinetic ...

FDA restrospective analysis of NHP monoclonal data supports streamlining nonclinical testing

Posted By Mark Arnold 05-11-2026 08:46
Found In Egroup: Translational and Clinical Science Community \ view thread
FDA's Nakissa Sadrieh and Yanning Hao just published an analysis of NHP data from monoclonal antibody testing that supports streamlining animal testing. For those interested in NAMs, the abstract draws you into to reading more with its brief summary of findings: "Among the mAbs evaluated, long-term ...

New FDA CMC guidance for Cell and Gene Therapy products

Posted By Mark Arnold 05-05-2026 21:26
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
FDA releases new final guidance "Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application". This guidance is brief at only 8 pages and is focussed at giving sponsors and manufacturers greater flexibility for CGT products ...

FDA publishes on NAMs in JAMA

Posted By Mark Arnold 04-20-2026 16:10
Found In Egroup: Translational and Clinical Science Community \ view thread
More insights from the FDA on implementing new approach methodologies were just published in JAMA. https://jamanetwork.com/journals/jama/fullarticle/2848148?resultClick=1 #fda #NAM ------------------------------ Mark Arnold Ph.D., FAAPS Westampton, NJ [email protected] Bioanalytical Solution ...

FDA releases draft guidance on Establishing Impurity Specifications for Antibiotics

Posted By Mark Arnold 04-17-2026 09:30
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
AAPS normally doesn't have a lot of discussion on antibiotics, but for those who work in this space, the Agency just released a new draft guidance "Establishing Impurity Specifications for Antibiotics". From the announcement: "The draft guidance provides recommendations regarding the establishment ...

ICH releases presentation on M15 MIDD

Posted By Mark Arnold 04-09-2026 08:00
Found In Egroup: Translational and Clinical Science Community \ view thread
ICH just released a presentation on "M15: General Principles for Model-Informed Drug Development" It provides an overview of M15 and notes several times that additional training materials will be developed. You can access the 23 slides here: https://database.ich.org/sites/default/files/ICH_Step_4_ ...