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21 Nov 2023, 4:44 am by Roger Bate
Public outcry led to the 1938 Federal Food Drug and Cosmetic Act (FDC), which required companies to perform product-safety tests prior to marketing. [read post]
26 Feb 2023, 9:05 pm by Blair Bean Robertson
These submissions would allow data to be used in a different matter to allow FDA to make regulatory decisions, given that the researcher performed an analysis with the submission of applications for new drugs, investigational new drugs (IND), and biologics licenses. [read post]
7 Feb 2023, 12:00 pm by Bernard Bell
”[9] The text of the statute and post-enactment changes in the health care industry meant that the court could not avoid judging what constituted reasonable availability of discounted pharmaceutical to covered entities. [read post]
4 Jan 2023, 2:22 am by Kurt R. Karst
  The Agency referred to its 2011 FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products during the town hall. [read post]
1 Nov 2022, 8:25 pm by Kurt R. Karst
The workshop included presentations by USP on its available standards for advanced therapies, FDA/CBER on CMC challenges for CART cell therapies, and industry approaches to potency testing during CART development, and using Analytical Quality by Design (AQbD) principles in potency assay development. [read post]
17 Oct 2022, 12:15 pm by sabrinaurso
Beyer’s publication to establish its Residential Apartment Lease Form, 5 Ind. [read post]
29 Sep 2022, 9:27 am by Greg Reeves
There are many metal fabrication shops and industries in Alabama that fabricate or manufacture stainless steel items.If so, call Greg Reeves today at 256-355-3311.For additional information:Am J Ind Med. 2000 Aug;38(2):115-26.Lung cancer among workers in chromium chemical production.OSHA  hexavalent chromiumCriteria for a Recommended Standard: Occupational Exposure to Hexavalent Chromium [read post]
7 Jul 2022, 5:32 am by Eugene Volokh
Such policy matters on the breadth of copyright protection should be left to the legislative branch in a manner consistent with the Constitutional directive to provide a limited monopoly to the creative industries of society. [read post]
19 Apr 2022, 6:15 am by Don Asher
Am J Ind Med. 1998 Oct;34(4):351-8. doi: 10.1002/(sici)1097-0274(199810)34:4<351::aid-ajim8>3.0.co;2-v. [read post]
13 Mar 2022, 6:57 am by David Adelstein
Miorelli explains that “[b]inding the sovereign to the implied covenants of an express contract is quite different from requiring a sovereign to pay for work not contemplated by that contract. [read post]
15 Dec 2020, 8:30 am by Eugene Volokh
[The same logic could apply when churches, synagogues, mosques, bookstores, gun stores, fur stores, and similar places are targeted by their enemies. [read post]
22 Jun 2020, 6:30 am by Rebecca Shafer, J.D.
ER:  Employer FCE: Functional Capacity Evaluation – a type of testing that measures an employee’s ability to perform various physical functions including lifting, twisting, bending, range of motion, etc. [read post]