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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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.
Roots Analysis
AUGUST 7, 2023
On the other hand, cell free system / cell free expression system are in-vitro platforms that harness the transcription and translation machinery of living cells, in the form of cell lysates, to synthesize various types of biologics, particularly proteins. Interestingly, most of these kits are used for cell-free protein expression.
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.
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).
FDA Law Blog
DECEMBER 6, 2023
The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.
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