Recommended Pages at fdalawblog.net
FDA Law Blog: GAO Report Criticizes DEA Diversion Control Performance Measures But Fails to Address Several Issues of Concern
fdalawblog.net — “By John A. Gilbert, Jr., Karla L. Palmer & Larry K. Houck – The Government Accountability Office (“GAO”) recently issued a report analyzing the Drug Enforcement Administration’s (“DEA’s”) efforts to combat the diversion of legal controlled substances and listed chemicals....” View full resource at fdalawblog.net
Most Recently Shared on October 7, 2011 at 2:20 pm By:
Scott Strumello Patient Expert
GAO Report Criticizes DEA Diversion Control Performance Measures But Fails to Address Several Issues of Concern http://t.co/MeOsEApN
FDA Law Blog: FDA Finalizes PDUFA User Fee Guidance
fdalawblog.net — “By Michelle L. Butler – On September 27th, FDA published a guidance document regarding user fee waivers, reductions, and refunds for drug and biological products. See 76 Fed. Reg. 59705 (Sept. 27, 2011); FDA, Guidance for Industry: User Fee Waivers,...” View full resource at fdalawblog.net
Most Recently Shared on September 28, 2011 at 3:26 pm By:
Scott Strumello Patient Expert
FDA Law Blog: FDA Finalizes PDUFA User Fee Guidance http://t.co/xViuzU6j
FDA Law Blog: HHS Issues Final Conflict of Interest Rules for PHS-Funded Research That Increases Burden to Institutions and Investigators
fdalawblog.net — “By Nisha P. Shah – The U.S. Department of Health and Human Services recently revised conflict of interest rules for Public Health Service ("PHS") related grants and research (i.e., the National Institutes of Health (“NIH”)) in response to congressional and...” View full resource at fdalawblog.net
Most Recently Shared on September 11, 2011 at 3:47 pm By:
Scott Strumello Patient Expert
HHS Issues Final Conflict-of-Interest Rules for PHS-Funded Research That Increases Burden to Institutins & Investigators http://t.co/F2pEeN5
FDA Law Blog: Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing
fdalawblog.net — “By Kurt R. Karst – On August 29, 2011, Public Citizen announced that it submitted a citizen petition to FDA requesting that the Agency amend its regulations to permit ANDA sponsors to revise their labeling through the Changes Being Effected...” View full resource at fdalawblog.net
Most Recently Shared on August 29, 2011 at 9:14 pm By:
Scott Strumello Patient Expert
FDA Law Blog: Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing http://t.co/q7UTAgV
FDA Law Blog: Congressional Leaders Request FDA to Exclude Grocery Stores from Menu Labeling Requirements
fdalawblog.net — “By Cassandra A. Soltis – In response to the Food and Drug Administration’s (“FDA’s”) proposed rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments, members of the U.S. Senate and House of Representatives have...” View full resource at fdalawblog.net
Most Recently Shared on August 19, 2011 at 2:47 pm By:
Scott Strumello Patient Expert
FDA Law Blog: Congressional Leaders Request FDA to Exclude Grocery Stores from Menu Labeling Requirements: http://t.co/4TngJBC
FDA Law Blog: Cosmetic Advertisement + Photoshop = Deceptive Advertising?
fdalawblog.net — “By Cassandra A Soltis – In a decision that could have implications in the United States, the U.K.’s Advertising Standards Authority (“ASA”), which describes itself as “the UK’s independent watchdog” that regulates advertising, found both a Lancôme and a Maybelline...” View full resource at fdalawblog.net
Most Recently Shared on August 5, 2011 at 6:02 pm By:
Strataderm for Scars Pharma and Health Social Media
FDA Law Blog - Cosmetic Advertisement + Photoshop = Deceptive Advertising? http://t.co/DUpCgPW
FDA Law Blog: FDA Reopens Comment Period for Gluten-Free Labeling of Foods
fdalawblog.net — “By Cassandra A. Soltis – The Food and Drug Administration (“FDA”) has reopened the comment period for its proposed rule on “gluten-free” labeling of food to announce the availability of, and seek comments on, its report titled “Health Hazard Assessment...” View full resource at fdalawblog.net
Most Recently Shared on August 5, 2011 at 12:14 am By:
Scott Strumello Patient Expert
FDA Law Blog: FDA Reopens Comment Period for Gluten-Free Labeling of Foods: http://t.co/bjaXTfp
FDA Law Blog: Clinical & Regulatory Strategies for Combination Products
fdalawblog.net — “Hyman, Phelps & McNamara, P.C.--™s Jeffrey K. Shapiro will be giving the state of the industry address at Q1 Productions--™ 2nd Annual Clinical & Regulatory Strategies for Combination Products, which is slated to take place in Baltimore, Maryland from July...” View full resource at fdalawblog.net
Most Recently Shared on April 26, 2011 at 2:30 pm By:
Q1 Productions Health Business
From the FDA Law Blog Clinical & Regulatory Strategies for Combination Products http://bit.ly/hg87CA
FDA Law Blog: Legislative Fixes Focus on Controlled Substance Issues
fdalawblog.net — “By Larry K. Houck -- Early March on Capitol Hill has seen a flurry of legislation designed to combat a number of perceived controlled substance problems, including opioid treatment, pain management, drugs marketed to kids and pill mills. Prescription Drug...” View full resource at fdalawblog.net
Most Recently Shared on March 24, 2011 at 3:49 am By:
Pain patients will bear greater burden - Legislative Fixes Focus on Controlled Substance Issues: http://bit.ly/h9S1Ci
FDA Law Blog: Judges Ask FDA: What is Natural?
fdalawblog.net — “By Ricardo Carvajal " In several cases that challenge food marketers' use of the term natural in labeling and advertising, the presiding judges have recently opted to suspend proceedings and seek an administrative determination from FDA as to whether high...” View full resource at fdalawblog.net
Most Recently Shared on September 7, 2010 at 2:00 pm By:
Dr Timothy Harlan - DrGourmet Internist, Physician, and Doctor
FDA Law Blog: Judges Ask FDA: What is “Natural� http://ow.ly/2zC0B
FDA Law Blog: FDA Determines That Pyridoxamine Is Excluded From the Definition of Dietary Supplement Under FDC Act 201(ff)(3)(B); Implications for FDA--™s Interpretation of 301(ll) Could Be Significant
fdalawblog.net — “By Diane B. McColl & Ricardo Carvajal -- In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning...” View full resource at fdalawblog.net
Most Recently Shared on April 9, 2010 at 10:47 pm By:
DrEliaz CAM, Integrative Physician, Physician, Acupuncturist, and Doctor
The FDA bans vitamin B6 as pyridoxamine. No longer a "supplement"...http://tinyurl.com/d76l5x
FDA Law Blog: Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation, Among Other Changes
fdalawblog.net — “By Kurt R. Karst " Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA's Fiscal Year 2011 budget request,...” View full resource at fdalawblog.net
Most Recently Shared on March 16, 2010 at 12:24 pm By:
FDALaw Blog: Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation. http://bit.ly/bxZnNb
FDA Law Blog: All for One and One for All " FDA Denies Graceway Petition on Generic ALDARA Cream
fdalawblog.net — “By Kurt R. Karst " Late last month, FDA denied a citizen petition submitted by Graceway Pharmaceuticals, LLC (Graceway) requesting that the Agency refuse to approve Abbreviated New Drug Applications (ANDAs) for generic versions of Graceway's ALDARA (imiquimod) Cream, 5%,...” View full resource at fdalawblog.net
Most Recently Shared on February 6, 2010 at 2:10 am By:
FDA Law Blog: All for One and One for All – FDA Denies Graceway Petition on Generic ALDARA Cream. http://bit.ly/bM5oXd
FDA Law Blog: Stipulation of Dismissal in Winston Laboratories Small Business User Fee Waiver Case
fdalawblog.net — “By Michelle L. Butler " This week, the parties in the Winston Laboratories case filed a Stipulation of Dismissal with Prejudice Pursuant to Fed. R. Civ. P. 41(a). This case involved FDA's interpretation of the term affiliate in its decision...” View full resource at fdalawblog.net
Most Recently Shared on February 6, 2010 at 2:09 am By:
FDA Law Blog: Stipulation of Dismissal in Winston Laboratories Small Business User Fee Waiver Case. http://bit.ly/dv3d84
FDA Law Blog: The Medicines Company Tosses Up a Hail Mary Pass " Sues PTO and FDA Over ANGIOMAX Patent Term Extension Decisions
fdalawblog.net — “By Kurt R. Karst " As we predicted, Massachusetts-based The Medicines Company (TMC) has sued the U.S. Patent and Trademark Office (PTO) and FDA in connection with the company's efforts to obtain a Patent Term Extension (PTE) for U.S. Patent...” View full resource at fdalawblog.net
Most Recently Shared on February 6, 2010 at 2:02 am By:
RT @IPThinkTank: Angiomax – US: The Medicines Company sues PTO and FDA over Angiomax patent term extension decisions http://bit.ly/bKCE7n
