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8 May 2013, 12:19 pm
In 2003, the Food and Drug Administration approved the use of growth hormone (GH) for the long-term treatment of idiopathic short stature (ISS), which refers to extreme short stature that does not have a diagnostic explanation, such as GH deficiency. [read post]
28 Mar 2013, 6:36 am by Debra A. McCurdy
It also authorizes the Food and Drug Administration to continue collecting industry user fees to fund agency operations. [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
25 Apr 2018, 7:39 am by Douglas A. Berman
., a senior legal research fellow in The Heritage Foundation’s Meese Center for Legal and Judicial Studies, has this interesting new Fox News commentary headlined "On marijuana, let the Food and Drug Administration make the decisions. [read post]
On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). [read post]
11 Jan 2017, 8:43 pm by Patent Docs
Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). [read post]
18 Apr 2017, 8:12 pm by Patent Docs
Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to predicting disease risk. [read post]
11 Jan 2011, 9:59 pm by Patent Docs
Noonan -- Members of Congress having sent their letter to the Food and Drug Administration on December 21st (see "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation"), on January 7th, it was the Senate's turn. [read post]
2 Nov 2023, 9:00 am
Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same. [read post]
11 Jan 2013, 4:59 am by Debra A. McCurdy
On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on “Accessible Standardized Medical Device Labeling." [read post]
7 Jan 2016, 11:46 am by m zamora
Attorney's Office for the Central District of California in conjunction with the Food and Drug Administration, the company said.Source: http://www.foxnews.com/us/2016/01/06/chipotle-hit-with-subpoena-in-federal-criminal-investigation.html [read post]
12 Oct 2023, 8:04 am by Bergeson & Campbell, P.C.
Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). [read post]
11 Apr 2018, 9:59 pm by Patent Docs
Food and Drug Administration (FDA) permitted marketing of a medical device that utilizes artificial intelligence to diagnose eye disease in diabetic adults. [read post]
13 Jun 2016, 10:00 am
., Board Certified by The Florida Bar in Health Law On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. [read post]
11 Apr 2017, 7:00 am by Brianna Smith
” Additionally, the CDC is also working with the “Florida department of heath and the federal Food and Drug Administration” to find out how a dead bat ended up inside a sealed package of salad. [read post]
8 Oct 2013, 12:22 pm
House of Representatives passed a bill that would allow the U.S Food and Drug Administration to have some oversight with compounding pharmacies. [read post]
11 May 2011, 7:31 am by Mitchell Garrett
Food and Drug Administration has ordered all producers of a popular category of artificial hip to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients. [read post]
14 Apr 2024, 10:00 pm
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). [read post]
9 Oct 2017, 3:06 am by Walter Olson
The Food and Drug Administration gets all dour and bureaucratic about a granola maker’s listing of “love” among its list of ingredients: “Your Nashoba Granola label lists ingredient ‘Love,’…‘Love’ is not a common or usual name of an ingredient. [read post]