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11 Apr 2011, 9:01 am by FDABlog HPM
Hyman, Phelps & McNamara's Ricardo Carvajal will be speaking on the Reportable Food Registry at the American Conference Institute’s 2nd Advanced Summit on Food Safety Regulatory Compliance, taking place in Chicago from June 15-16, 2011. [read post]
7 Apr 2011, 5:47 pm by FDABlog HPM
By Ricardo Carvajal – FDA has a web page devoted to the Food Safety Modernization Act (“FSMA”) that provides ready access to useful information on the new law and on FDA’s implementation activities, including: the text of the law; Q&A’s; descriptions of the work groups charged with implementation; the text of relevant speeches by the Commissioner and Deputy Commissioner for Foods; interviews with senior staff; archived webcasts of public meetings; and… [read post]
29 Mar 2011, 9:32 pm by FDABlog HPM
By Ricardo Carvajal - At FDA’s public meeting on the food import safety provisions of the Food Safety Modernization Act ("FSMA") (see our prior blog posting here), the challenges posed by implementation of those provisions started to take shape. [read post]
23 Mar 2011, 7:38 pm by FDABlog HPM
By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. [read post]
23 Mar 2011, 12:19 pm by FDABlog HPM
By Ricardo Carvajal – Last week FDA published a Q&A that explains steps the agency is taking to ensure that foods imported from Japan are safe. [read post]
10 Mar 2011, 9:47 pm by FDABlog HPM
By Ricardo Carvajal -  In an upcoming issue of the Federal Register, FDA is announcing a public meeting scheduled for March 29 to solicit comment on the import safety provisions of the Food Safety Modernization Act ("FSMA"). [read post]
23 Feb 2011, 5:32 pm by FDABlog HPM
By Ricardo Carvajal – In a letter directed to Attorney General Eric Holder, Senator Patrick Leahy (D-VT) asked the U.S. [read post]
18 Feb 2011, 4:59 pm by FDABlog HPM
By Ricardo Carvajal – Totally Wicked-E.Liquid (“TWI”), an importer and distributor of electronic cigarettes, filed suit to prevent FDA from regulating TWI’s electronic cigarettes as drugs, devices, or combination products, and from barring their importation into the U.S. [read post]
1 Feb 2011, 8:28 pm by FDABlog HPM
By Ricardo Carvajal – Senator Patrick Leahy (D-VT) reintroduced legislation to strengthen criminal penalties for food safety violators in the form of the Food Safety Accountability Act of 2011. [read post]
24 Jan 2011, 10:38 am by FDABlog HPM
By Ricardo Carvajal – When FDA issued a report on the Reportable Food Registry ("RFR") 7 months after the RFR’s implementation, the agency cautioned that it was “too early to draw inferences concerning patterns of food and feed adulteration. [read post]
23 Jan 2011, 12:59 pm by FDABlog HPM
By Ricardo Carvajal - The Government Accountability Office ("GAO") issued a report recommending in part that FDA “identify and request from Congress the authorities needed to access evidence from food companies regarding potentially false or misleading structure/function or other claims on food that would allow the agency to establish whether there is scientific support for the claims. [read post]
20 Jan 2011, 10:14 am by Kenneth Odza
I'll be moderating with Ricardo Carvajal a panel of experts on the FSMA including Robert Brackett (formerly head of CFSAN), Art Liang from CDC, Miriam Guggenheim and Fred Degnan. [read post]
13 Jan 2011, 2:10 pm by FDABlog HPM
By Ricardo Carvajal & Wes Siegner – As we would wager is true of all major pieces of legislation, the Food Safety Modernization Act (“FSMA”) can be expected to have significant unanticipated consequences. [read post]
11 Jan 2011, 1:13 pm by FDABlog HPM
’s Ricardo Carvajal will be co-moderator for a session on the impact of the Food Safety Modernization Act and other reforms on the food industry. [read post]
5 Jan 2011, 2:15 pm by FDABlog HPM
By Ricardo Carvajal – The Food Safety Modernization Act ("FSMA") is now law. [read post]
4 Jan 2011, 5:21 am by FDABlog HPM
McColl & Ricardo Carvajal – On December 28th, FDA reopened the public comment period for its 1997 proposed rule that outlined the voluntary GRAS notification process intended to replace the voluntary GRAS affirmation petition process. [read post]