2018 IT Manufacturing Specialization 
The Medical Futurist
JUNE 21, 2025
Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! What about the smell of the flowers?
FDA Law Blog
SEPTEMBER 26, 2022
Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §
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FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The main body of the draft guidance provides high-level recommendations, and four appendices provide detailed recommendations for test design. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,
FDA Law Blog
OCTOBER 25, 2021
It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. The new rule will be codified in 21 C.F.R. Part 860.
FDA Law Blog
JUNE 10, 2025
DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.
FDA Law Blog
MAY 14, 2021
In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §
FDA Law Blog
MAY 14, 2021
In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §
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