Search for: "The Regulatory Review Staff"
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24 Jul 2008, 8:58 pm
Resource Requirements: increase regulatory agency budgets and staffing. [read post]
15 May 2025, 8:50 pm
He spoke with obvious enthusiasm about the recently announced pilot AI-assisted review and its potential to shave weeks off approval timelines, as he described hearing from one reviewer in the pilot project who said the pilot AI tool completed three days’ work in gleaning salient facts from medical literature in six minutes. [read post]
1 Sep 2017, 6:48 am
Information on policies and practices should be shared among supervisors; supervisors should review their current regulatory, supervisory and licensing frameworks in light of new and evolving risks arising from innovative products and business models. [read post]
10 Feb 2021, 8:08 am
This year was no exception: on January 20, 2021, the new White House Chief of Staff Robert Klain issued a memorandum with the subject line “Regulatory Freeze Pending Review” to all executive agencies. [read post]
4 Oct 2015, 5:24 pm
These ideas will help prevent regulatory delay from blocking the launch of new products. [read post]
18 May 2025, 9:01 pm
Robust economic analysis of our regulatory initiatives helps us to do just that. [read post]
11 Dec 2023, 8:33 pm
Regulatory affairs professionals with significant expertise in diagnostics are already in short supply. [read post]
4 May 2025, 2:15 pm
Administrative and Fiscal Considerations MDE is now authorized to collect a $100 fee to review annual benchmarking reports submitted by building owners. [read post]
2 May 2012, 7:22 pm
Both Senators have long criticized FDA, saying that the Agency‘s “regulatory malaise” harms patients and manufacturers. [read post]
21 Dec 2023, 11:23 am
Scientific papers authored by our staff and published in 2023 are making waves in the scientific community: Our peer-reviewed scientific paper in the journal Critical Reviews in Toxicology analyzed data from the 90-day pesticide test on beagles to demonstrate that, in nearly all cases, the test provided no added value in protecting humans from pesticides’ toxic effects. [read post]
11 Jul 2008, 4:30 am
Part I – Spicy IP), India: Discussion of grant of Indian patents to Cipla for Fosamax derivative and Nexium derivative: (Spicy IP), India: Draft National Biotechnology Regulatory Authority Bill: (Spicy IP), Ivory Coast: Ivorians increasingly choose fake medicines on price: (Afro-IP), Mexico: New Mexican medicaments approvals regime: an early report: (IP tango), UK: Leave to appeal refused in trade mark infringement proceedings between Eli Lilly and 8PM Chemist concerning the… [read post]
22 Nov 2022, 10:11 am
In reviewing our blog when writing this article, we noted that in the almost 17 years we have been publishing, we don’t seem to have ever referred specifically to the question of reversionary or retained interests in a broadcast station. [read post]
6 Nov 2021, 5:34 am
However, it might be helpful to review the events that led to the bill’s introduction. [read post]
13 Sep 2022, 3:48 am
As we have seen though, regulatory and disciplinary options may be limited. [read post]
6 Mar 2023, 5:47 am
Issues like the EU’s latest regulatory push or recent U.S. [read post]
28 Apr 2015, 8:59 am
National / International News <> SAB Review of the EPA's Draft Technical Guidance for Assessing Environmental Justice in Regulatory Analysis - The Science Advisory Board (SAB) reviewed EPA's the draft report titled Technical Guidance for Assessing Environmental Justice in Regulatory Analysis ("EJTG"). [read post]
19 Dec 2011, 12:33 pm
Congress is currently considering the SEC Regulatory Accountability Act, which would require the Securities and Exchange Commission to review its regulations periodically to determine if they are "outmoded, ineffective, insufficient or excessively burdensome, and to modify or repeal them in accordance with such review. [read post]
22 Jun 2010, 9:46 am
Reviews Corrective Action Statements associated with US, Canada, and/or other regulatory agencies. [read post]
20 Dec 2018, 2:43 pm
The three directives, titled DIR 2019-01 (regarding “Compliance Review Procedures”), DIR 2019-02 (regarding “Early Resolution Procedures”), and DIR 2019-03 (regarding “Opinion Letters and Help Desk”) were issued to “provide guidance to OFCCP staff or federal contractors on enforcement and compliance policy [and] procedures. [read post]
29 Apr 2013, 5:39 am
I propose that volunteers can be rounded up into task force assignments in order to handle various regulatory requirements cheaply rather than by hiring a vendor. [read post]
