• When are Postmarketing Trials Required for Medical Devices? New FDA Guidance Explains

    Earlier this week, the US Food and Drug Administration (FDA) launched the Expedited Access Premarket Approval program (EAP) , a new program aimed at getting innovative medical device products to needy patients more quickly by expediting the regulatory review of the products and their manufacturing processes. But in addition to the guidance document detailing the program, FDA also issued a draft guidance document on which clinical data FDA will expect companies to have a...
  • New FDA Guidance Tries to Define When Antibody Products are 'The Same'

    A new guidance document released this week by the US Food and Drug Administration (FDA) aims to clarify the interaction of the 2012 Biologics Price Competition and Innovation Act (BPCI) and the 1983 Orphan Drug Act with respect to monoclonal antibody products. Background FDA's orphan drug regulations are intended to create market-based incentives for manufacturers of products for populations with rare diseases. Per the  Orphan Drug Act , a rare disease is defin...
  • FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

    • 23 October 2012
    The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement and the Obama administration's already complicated relationship with the pharmaceutical industry, reports Reuters . The agreement in question is known as the Transpacific Partnership (TPP)-a regional trade policy long under negotiation and periodically subject to trans...
  • Watson Files Suit Against FDA over 180-Day Exclusivity

    Generics manufacturer Watson Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) in an attempt to compel the agency to grant it 180-day generic marketing exclusivity for its generic version of anti-diabetes drug Actos (pioglitazone). Under a 2010 settlement between Actos' manufacturer, Takeda Pharmaceuticals of Japan, Watson, Mylan Inc and Ranbaxy Laboratories all received what Watson referred to as "shared exclusivity." Under normal c...
  • GHTF Releases Adverse Event Report Standard for Pre-Clinical Trials

    The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final document on its SG5:N5:2012 clinical trials adverse event reporting standard. The standard, Reportable Events During Pre-Market Clinical Investigations , released 10 August 2012, is the product of GHTF's Study Group 5 (SG5) -a group charged with harmonizing clinical safety...
  • Orphan Drug Marketing Exclusivity Revoked from Product as FDA Admits Error

    In a groundbreaking move, the US Food and Drug Administration (FDA) moved to rescind marketing exclusivity for an orphan drug product manufactured by OctaPharma used for the treatment of von WIllebrand disease (VWD), a hereditary bleeding disorder. OctaPharma's VWF drug Wilate, a Factor VIII concentrate, received approval from FDA on 30 November 2009 for the treatment of severe VWF and mild to moderate VWF in patients where an existing therapy, desmopressin, proved ine...
  • Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions

    • 13 June 2012
    Two Democratic legislators this week sent a letter to members of the Senate's and House of Representatives' healthcare oversight committees detailing the findings of the legislators' investigation into the effects of the so-called "gray market" on prescription drug shortages. In their 11 June letter, Senator Jay Rockefeller (D-WV) and Representative Elijah Cummings (D-MD) said their investigation had "identified significant risks in the US pharmaceutical distribution cha...
  • New Bill Hopes to Curb Drug Shortages, Price Gouging

    • 23 May 2012
    A new bill proposed by Rep. Elijiah Cummings aims to curb drug shortages resulting from so-called "gray market" drug sales where companies purchase stock of medicines experiencing shortages and exorbitantly mark up prices to subsequent purchasers. "Nobody should be allowed to engage in profiteering at the expense of children and adults with cancer or other critical illnesses by jacking up the price of drugs that are in critically short supply," said Cummings.  ...
  • FDA Approves Generic Lexapro

    The US Food and Drug Administration (FDA) today approved Israeli pharmaceutical manufacturer Teva Pharmaceutical Industries to legally market generic Lexapro for depression and generalized anxiety disorder in adults. Teva has been granted 180 days of marketing exclusivity, during which FDA is not allowed to approve any other generic version of Lexapro, originally manufactured by Forest Laboratories. Teva's Abbreviated New Drug Application (ANDA) for Lexapro was original...
  • EC Proposes Streamlining Pricing, Reimbursement Decisions

    • 02 March 2012
    The European Commission (EC) wants drugs to reach the market faster and is proposing changes to the pricing and reimbursement process. In a report by PMLive Intelligence Online , revisions to the Transparency Directive for set a 120-day limit for national regulators on innovative medicines and a 30-day limit for generics. Currently, countries have up to 180 days to decide if a drug can be marketed, but some have stretched to 700 days for innovative medicines approval. ...
  • Administration Budget Forcefully Against 'Pay-For-Delay,' Industry

    The Fiscal 2013 federal budget released on 13 February by the Obama administration laid out more than just the proposed spending levels for dozens of federal agencies, including the US Food and Drug Administration (FDA). Buried in the several-hundred page budget document are indications that the Obama administration intends to forcefully move against 'pay-for-delay' settlements that the Federal Trade Commission (FTC) considers to be "anticompetitive," biologic exclusivity...