2 days ago

by Brian J. Malkin On February 7, United States District Judge Amy Berman Jackson granted defendant FDA's motion for summary judgment and denied plaintiff Sanofi-Aventis's ("Sanofi's") cross-motions in Sanofi's challenge of FDA's decision of a citizen petition filed by Sanofi regarding generic versi ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

29 days ago

by Scot B. Pittman FDA's Center for Veterinary Medicine ("CVM") announced last week that it was restricting the use of certain antibiotics in farm animals. On January 6, 2012, CVM published a final rule in the Federal Register that prohibits certain uses of cephalosporin drugs in food-producing anim ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

36 days ago

by Scot B. Pittman On January 3, FDA released proposed amendments to its regulations governing submitting citizen petitions and petitions for stay of action ("PSAs") that involve requests for FDA to take action regarding pending abbreviated new drug applications ("ANDA") or 505(b)(2) new drug applic ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

43 days ago

by Brian J. Malkin On December 27, FDA issued a draft guidance, " Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices," which was jointly issued by the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

84 days ago

by Scot B. Pittman On November 7, FDA denied two citizen petitions related to the use of certain antibiotics in food animal production. A 1999 Petition, submitted on behalf of the Center for Science in the Public Interest ("CSPI"), the Environmental Defense Fund, the Food Animal Concerns Trust ("FAC ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

90 days ago

by Scot Pittman Hill Dermaceuticals, Inc. has sued the Food and Drug Administration in the District Court for the District of Columbia over the approval of three Abbreviated New Drug Applications ("ANDAs") submitted by Identi Pharms, Inc. Hill seeks the immediate withdrawal or suspension of FDA's ap ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

112 days ago by Pauline

If I got my news from TV, perhaps I’d have heard of this before. I haven’t listened to any of Obama’s speeches, or anyone’s analysis and commentary on his speeches. I may have seen a brief mention of the “ We the People” website last month, but didn’t bother to find out what it was about. It was an ...

Perennial Student - paulinege.wordpress.com · Rank: 101,551 · 27 references

149 days ago

by Fitz Beckwith Collings The Center for Inquiry ("CFI") and its affiliate, the Committee for Skeptical Inquiry ("CSI") - want to know why FDA has not yet regulated the labeling and sale of homeopathic drugs. On August 26, the organizations jointly filed three citizen petitions requesting that FDA " ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references

161 days ago

by Brian J. Malkin On August 19, the Natural Resources Defense Council, Inc. ("NRDC") sued FDA for declaratory and injunctive relief for FDA to grant NRDC's citizen petition to remove the chemical bisphenol A ("BPA") from food packaging and other products where it comes in contact with food. NRDC al ...

FDA Lawyers Blog - fdalawyersblog.com · Rank: 147,816 · 9 references