FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Tobolowsky & Charles G. Raver & James E.

Therapies 59

Therapies FDA Production Disease 59

Drug Target Review

SEPTEMBER 10, 2024

FDA no longer has to require animal testing for new drugs. 2024:24-26 About the authors Alejandro Fernandez Martell, Global Principal Scientist, Lonza Alejandro is a Global Principal Scientist at Lonza with a main focus on Upstream Process Development. References: 1 Wadman M. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al.

Drug Development 64

Drug Development Clinical Supply Production Protein Expression 64

Agency IQ

JANUARY 26, 2024

BY LAURA DIANGELO, MPH | JAN 23, 2024 12:15 AM CST Orthopedic, implanted medical devices and coatings: Regulatory recap Medical device materials, and coating: In general, the types of materials and components of which medical devices are constructed need to be evaluated for their impact on a device’s performance and safety. What’s next?

FDA 40

FDA Animal Testing Packaging Regulations 40

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 final rule is expected in April 2024. BY PATRICIA ISCARO, ESQ. |

Animal Testing 40

Animal Testing Regulations Production Marketing 40

Agency IQ

MARCH 7, 2024

BY SCOTT STEPHENS, MPA | MAR 7, 2024 8:21 AM CST The format: an emphasis on conversations ECHA’s one-day event , titled “Shaping Tomorrow,” was held at the agency’s headquarters in Helsinki, Finland and live-streamed on ECHA’s website. Among the topics: stakeholder cooperation in the context of the green and digital transition.

Regulations 40

Regulations International Government Compliance 40

Agency IQ

JANUARY 19, 2024

BY RAYAN BHARGAVA, MSC | JAN 11, 2024 6:55 PM CST Regulatory background A 2019 fitness check of the most relevant chemical regulations found that protection afforded to human health and the environment was of a suitably high standard, although issues with consistency and efficiency were evident.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

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. Finally, MDCG 2024-3 outlines the expected content for a clinical investigation plan and MDCG 2024-5 describes the content of the investigator’s brochure.

Trials 40

Trials Marketing Clinical Trials Regulations 40

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research 112

Research Engineering Disease Science 112

PLOS: DNA Science

APRIL 4, 2024

.” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” It debuted in January 2024 , but the company has been around since 2015. ” Manufacturers can use existing safety data on each ingredient and on similar products.

Disease 98

Disease Production Testimonials FDA 98

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. increase in base salaries for federal workers in 2024, which started in January.

FDA 40

FDA Packaging Science Drugs 40

Codon

NOVEMBER 1, 2024

Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animal testing — I hope others will take on these challenges in similar essays. A complete neuronal wiring diagram of a fruit fly brain, consisting of about 140,000 neurons, was published in October 2024.

DNA 107

DNA RNA Molecular Biology Laboratories 107

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. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

Regulations 40

Regulations FDA Science Production 40

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Animal Testing 57

Animal Testing FDA Analytical Chemistry International 57

Codon

JUNE 2, 2024

” It’s an uncharitable take, but when drugs fail as often as they do despite animal testing, it’s not hard to see the JAX mice as a metaphor for a biomedical enterprise cloistered away from the real world. ” Asimov Press (2024). Cite this essay: Alex Telford. “The Mouse as a Microscope.”

Laboratories 117

Laboratories Research Disease Science 117