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In our paper, The Twilight Zone: OTC Regulatory Regimes and Market Quality, which was recently made publicly available on SSRN, my co-authors (Ulf Bruggemann, Aditya Kaul, and Ingrid Werner) and I analyze the association between these regulatory regimes and market quality. [read post]
1 Jan 2019, 9:00 am by Michael H Cohen
Active Ingredients: The product contains “only suitable inactive ingredients which are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity. [read post]
19 Apr 2019, 2:24 pm by Lynn L. Bergeson and Carla N. Hutton
  As reported in our February 21, 2019, blog item, “FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials,” FDA invites comment on the following topics: Specific nanomaterials or types of nanomaterials that have been used or proposed for use in OTC sunscreen products; Concerns about sunscreen product safety, effectiveness, or quality associated with the use of nanomaterials in OTC sunscreen products, with… [read post]
21 Feb 2019, 7:35 pm by Lynn L. Bergeson and Carla N. Hutton
” FDA invites comment on the following topics: Specific nanomaterials or types of nanomaterials that have been used or proposed for use in OTC sunscreen products; Concerns about sunscreen product safety, effectiveness, or quality associated with the use of nanomaterials in OTC sunscreen products, with supporting data; Need for, and proposals of, specifications or limitations for particular nanomaterials for use in OTC sunscreen products; Any particular… [read post]
10 Dec 2010, 8:08 am by James Hamilton
It also helps increase transparency in the market, promotes standardization, and provides a level of consistency in the quality and availability of transaction data.Central clearing of OTC derivatives trades helps reduce counterparty risk in a financial system and is conducive to effective regulatory oversight of the trades. [read post]
25 Jan 2010, 9:02 am by Lebowitz & Mzhen
McNeil Consumer Healthcare, the J&J subsidiary that sells the drugs is voluntarily recalling the lots of the Over-The-Counter (OTC) products, in an effort to maintain the health and safety of the consumer, and to prevent OTC medication errors. [read post]
3 Jul 2012, 1:43 pm by James Hamilton
The G-20 also supports continuing work to achieve convergence to a single set of high-quality accounting standards. [read post]
8 Nov 2023, 3:01 pm by Kurt R. Karst
  The New York Times recently pointed out a considerable range of quality among OTC hearing aids that are currently on the market. [read post]
21 Jun 2009, 6:11 am
The retail defendants claim to have quality control standards to monitor supplements from the vendors it uses. [read post]
2 Apr 2011, 10:29 am by James Hamilton
In a letter to the Commissions, BIS said that it enters into a limited range of OTC derivatives transactions with financial counterparties that, because of the bank’s high credit quality, pose no risk to financial systemic stability. [read post]
17 Aug 2022, 7:30 pm by Kurt R. Karst
  FDA also clarified that all hearing aids, OTC or otherwise, are subject to Quality System Requirements (“QSRs”). [read post]
22 Jun 2023, 7:39 pm by Kurt R. Karst
  Collection device manufacturers that develop innovative collection device designs, intended to make it easy for a lay user to collect an adequate sample of the correct volume and quality, are often thwarted when they approach the Agency seeking clearance. [read post]
29 Apr 2013, 4:43 pm by Graham Noyes
  CME Group and ICE will enable over the counter trading (OTC) of D4 RINs, D5 RINs, and D6 RINs. [read post]
23 Oct 2011, 9:33 am by James Hamilton
The G-20 Finance Ministers and Central Bankers have reaffirmed their commitment to implement the regulation of OTC derivatives in a globally consistently and nondiscriminatory manner. [read post]
28 Jul 2013, 4:00 am by James Hamilton
Agreement on cross-border issues related to OTC derivatives reforms as a major constructive step forward, which paves the way for resolving remaining conflicts, inconsistencies, gaps and duplicative requirements globally. [read post]
3 May 2011, 6:44 am
While it's heartening to realize that the pharmaceutical companies and medicine have been able to increase the length and quality of life - this progress comes with risks. [read post]
16 Aug 2022, 4:55 pm by Sabrina I. Pacifici
  The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public. [read post]
30 Aug 2013, 2:27 pm by James Hamilton
For example, requiring OTC derivatives users to hold more high-quality, low-yielding assets as collateral lowers their income. [read post]
13 May 2009, 4:01 pm
Supervisors evaluated loss rates for similar portfolios using consistent data and metrics, allowing them to identify outliers and more effectively evaluate the quality of individual firm estimates. [read post]
14 Mar 2011, 11:00 am by Lucas A. Ferrara, Esq.
McNeil Consumer Healthcare Division's Vice President of Quality and the company's Vice President of Operations for OTC Products also were named defendants in the consent decree, filed with the U.S. [read post]