biologics

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Latest blogosphere posts tagged “biologics”

 

• While We’re Waiting on Bartlett, Some New Preemption Challenges to Consider

  
  FDA Law Blog — Authority: 479
  By Kurt R. Karst –       As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here ), we thought we would whet the preemption appetite ...
  3 days ago

• Generic and Innovator Drugs: The Next Generation

  
  FDA Law Blog — Authority: 479
  By Kurt R. Karst –       Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who , Star Wars , and, of course, Star Trek .  I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun).  I ...
  2 weeks ago

• FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate

  
  FDA Law Blog — Authority: 479
  By Kurt R. Karst –       By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York that FDA, within 30 days, make ...
  2 weeks ago

• False Friends: FDA’s “Gift” on NESINA – Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken

  
  FDA Law Blog — Authority: 479
  By Kurt R. Karst –       Frau Rommelfanger’s seventh grade German class: that’s where we first learned to appreciate “false friends,” which are pairs of words or phrases in two languages that look or sound alike, but differ significantly in meaning.  Never write the word “gift” on a package to ...
  2 weeks ago

• FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures?

  
  FDA Law Blog — Authority: 479
  By Kurt R. Karst –       Bayer HealthCare, LLC’s (“Bayer’s”) court challenge to FDA’s approval of Abbreviated New Animal Drug Application (“ANADA”) No. 200-495 submitted by Norbrook Laboratories, Ltd. (“Norbrook”) for Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal ...
  3 weeks ago

• Senate’s HELP Committee Releases Draft Compounding Legislation; Seeks Stakeholders’ Written Comments by May 3, 2013

  
  FDA Law Blog — Authority: 479
  By Karla L. Palmer – The Senate’s Health, Education, Labor and Pensions (“HELP”) Committee released draft legislation on Friday, April 26, 2013, that would replace section 503A of the Federal Food, Drug & Cosmetic Act (“FDCA”), amend other sections, and clarify FDA’s authority to regulate ...
  3 weeks ago

• The Venture Café Hosts Life Sciences Week - FLH Partner Brian J. Malkin Holds Office Hours 3-5pm

  
  — Authority:
  This week The Venture Café in Cambridge, Massachusetts hosts Life Sciences Week with a special focus on life science research in the Greater Boston area. Featured life science research speakers include Akrivis (ADAPT™ technology, which allows cancer detection much earlier by increasing the sensitivity of early ...
  3 weeks ago

• DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year Exclusivity

  
  FDA Law Blog — Authority: 479
  By Kurt R. Karst –       In a brief opinion handed down last week by the U.S. Court of Appeals for the District of Columbia Circuit, the Court affirmed a July 5, 2012 decision from the U.S. District Court for the District of Columbia granting summary judgment for FDA in a case brought by AstraZeneca ...
  3 weeks ago

• FDLIs Annual Meeting Features FDA Seeking More Resources and Regulatory Authority and More (Part 2 of 2)

  
  — Authority:
  This blog is a second part to a blog here, describing Annual Conference for the Food and Drug Law Institute ("FDLI") held on April 23 and 24, 2013, its in Washington, D.C. On the first day, FLH Partner Brian J. Malkin spoke on a panel discussing the priorities for the Center for Biologics Evaluation and Research ...
  3 weeks ago

• Tracking and Tracing Congress’ New Track and Trace Bills

  
  FDA Law Blog — Authority: 479
  By Jessica A. Ritsick & William T. Koustas – Within the last week, members of health committees in the House and Senate unveiled draft bills addressing prescription pharmaceutical supply chain security.  The House Energy & Commerce Committee is set to hold a hearing on the House bill on April 25, ...
  3 weeks ago

• Court Rules in Novel False Claims Act Case Where One Pharmaceutical Company Sues Another

  
  FDA Law Blog — Authority: 479
  By Delia A. Stubbs –   The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor.  In Amphastar Pharm., Inc. v. ...
  4 weeks ago

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