Cosmetics In-Vitro Research 
Medical Xpress
JANUARY 26, 2023
Bioengineered artificial skin has become an increasingly important and reliable platform for researchers to test the safety and efficacy of drugs and cosmetics. The most promising technologies for production of in vitro models include 3D bioprinting.
ProRelix Research
JUNE 26, 2023
As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.
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FDA Law Blog
AUGUST 18, 2024
Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.
pharmaphorum
OCTOBER 27, 2022
These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. What is the scope of the Guidance? Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.
Delveinsight
JANUARY 6, 2021
The most prominent healthcare services opted to include cosmetic surgery, dentistry, orthopedic surgery, cardiac surgery , and organ transplantation. Simultaneously, the demand for assisted reproductive technology like in vitro fertilization and surrogacy is also increasing at a rapid pace.
FDA Law Blog
FEBRUARY 2, 2023
The law defines this term to mean “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.” Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).
Roots Analysis
AUGUST 15, 2023
Overview of Cell Free Systems Cell-free systems are in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. In addition to the healthcare industry, other industries, such as food industry, cosmetics industry and enzyme synthesis industry, are also benefiting from the cell free manufacturing process.
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