Search for: "In Re FD Processing"
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21 Feb 2024, 6:10 pm
In the proposed rule, FDA had proposed requiring manufacturers to “obtain the signature for each individual who approved or re-approved the record” (proposed § 820.35). [read post]
12 Nov 2023, 9:01 pm
FDA notes that these serovars are not explicitly addressed in the shell egg regulation; however, they are human pathogens that can cause food to be adulterated under the FD&C Act. [read post]
8 May 2023, 9:14 pm
Re–training practices: The MP should state whether the model will need to be re-trained. [read post]
1 Feb 2023, 9:01 pm
But the story really begins with the statute that created the public registration process—the Securities Act of 1933. [read post]
18 Nov 2022, 6:30 am
Posted by the Harvard Law School Forum on Corporate Governance, on Friday, November 18, 2022 Editor's Note: This roundup contains a collection of the posts published on the Forum during the week of November 11-17, 2022 Illustrative Disclosure for the SEC’s New PVP Rules Posted by Mike Kesner, Linda Pappas, Pay Governance LLC, on Friday, November 11, 2022 Tags: Compensation disclosure, Disclosure, pay versus performance, SEC, Shareholder value, TSR Fair Value as Process: A… [read post]
18 Nov 2022, 6:30 am
Posted by the Harvard Law School Forum on Corporate Governance, on Friday, November 18, 2022 Editor's Note: This roundup contains a collection of the posts published on the Forum during the week of November 11-17, 2022 Illustrative Disclosure for the SEC’s New PVP Rules Posted by Mike Kesner, Linda Pappas, Pay Governance LLC, on Friday, November 11, 2022 Tags: Compensation disclosure, Disclosure, pay versus performance, SEC, Shareholder value, TSR Fair Value as Process: A… [read post]
8 Nov 2022, 8:56 pm
Below, we re-create information shared by Dr. [read post]
12 Aug 2022, 4:24 am
To be clear, even in the absence of living stem cells, amniotic fluid and membrane products may still be helpful in the cell regenerative process. [read post]
30 Jul 2021, 11:16 am
See In re Zofran, No. 1:15-md-2657-FDS, MDL Order No. 27 (D. [read post]
27 Jun 2021, 9:01 pm
” Further, their hazard analysis identified allergens as a chemical hazard with justification stated as the product is processed in a facility that also processes peanut, egg, fish, tree nut, wheat, milk, and soybean. [read post]
23 Apr 2021, 3:03 am
But now we’re in the age of stonks – and no-fee trading platforms. [read post]
15 Jan 2021, 2:40 pm
With this consent decree, we’re taking action to protect Americans, including children in this case, from consuming foods that have been processed in violation of the law,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. [read post]
15 Nov 2020, 9:01 pm
They further stated that they “understand we need to document all actions taken in our re‐evaluation process” but they have failed to provide FDA with written documentation of any action they have taken (such as a recent audit report that includes a review of their foreign supplier’s environmental monitoring program and their documented review and assessment of that report). [read post]
6 Oct 2020, 3:03 am
The topics include: – SEC Engages in a Flurry of Rulemaking – Regulation FD Turns 20: Our Take – Something to Look Forward to in 2021: Less Non-Issuer Financial Information – Lynn Jokela [read post]
13 Jul 2020, 5:00 am
Although they are listed in the U.S., they’re subject to a "much relaxed" corporate governance and disclosure regime because they're not subject to important rules like Reg FD or releasing ownership reports or quarterly audit reports. [read post]
2 Apr 2020, 5:16 am
Back in the summer of 2019, Judge Saylor, the MDL judge presiding over the Zofran birth defect cases, ordered epidemiologist, Dr. [read post]
3 Mar 2020, 9:01 pm
The violations noted by the FDA: “You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. [read post]
6 Jan 2020, 12:19 am
Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. [read post]
15 Dec 2019, 9:01 pm
., swabs) from various areas in your processing facility. [read post]
22 Sep 2019, 9:01 pm
“During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. [read post]
