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13 Feb 2022, 10:00 pm
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors. [read post]
13 Feb 2022, 10:00 pm
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors. [read post]
13 Feb 2022, 10:00 pm
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors. [read post]
18 Feb 2024, 9:38 pm by Etelka Bogardi (HK) and Conrad Lam
Licensed VA OTC service providers can remit VA OTC transaction proceeds for clients on specified conditions. [read post]
12 Jan 2009, 2:41 pm
The FDA has issued final guidance on “Labeling OTC Human Drug Products—Questions and Answers. [read post]
27 Dec 2009, 3:42 pm by Frank Pasquale
Opaque OTC derivative markets: "worse than casinos"? [read post]
28 Dec 2013, 9:06 am by m zamora
Women looking for a quick fix to those problems may be attracted to supplements that promise to boost thyroid function.More here: http://www.medpagetoday.com/Endocrinology/Thyroid/43501http://dietarysupplementreporter.wordpress.com/2013/12/28/otc-thyroid-boosters-may-harm/ [read post]
27 Jul 2022, 6:59 am by Simon Lovegrove (UK)
On 25 July 2022, the European Securities and Markets Authority (ESMA) updated its list of third-country markets considered as equivalent to a regulated market in the Union for the purposes of the definition of the OTC derivatives. [read post]
24 Feb 2014, 2:19 pm by Debra A. McCurdy
The inability of the current OTC Drug Review to easily accommodate innovative changes to OTC products. [read post]
16 Oct 2012, 10:43 am by Cadwalader
Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC Derivatives, Central Counterparties and Trade Repositories (“EMIR”) was introduced to provide a framework to improve the functioning of the OTC derivatives markets in the European Union. [read post]
29 Mar 2023, 5:58 pm by Kurt R. Karst
How “accessible” will OTC naloxone really be? [read post]
25 Nov 2011, 3:00 pm by Stikeman Elliott LLP
The Canadian Securities Administrators released a consultation paper today addressing the regulation of OTC derivatives markets. [read post]
7 Sep 2013, 1:10 pm by James Hamilton
  Two new regulated activities were proposed to be regulated involving the activities of dealers and advisers in relation to OTC derivatives transactions, as well as clearing agents in OTC derivatives under the OTC derivatives regime. [read post]
21 Sep 2010, 9:05 am by Stikeman Elliott LLP
Among other things, the proposals would require trades in OTC derivatives in the EU to be reported to central data centres (trade repositories) accessible to regulators. [read post]
13 Jul 2009, 11:14 am
Treasury Secretary Timothy Geithner outlined the steps the Obama Administration intends to take to regulate OTC derivatives in testimony to Congress on July 10. [read post]
26 Feb 2014, 8:01 am by Lisa Baird
” This hearing will be a major step in FDA’s long-standing plan to overhaul the OTC drug system. [read post]