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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (10 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Committee Rejects Sanofi’s Request for Dengue Vaccine Trial Waiver A top-ranking Indian health committee has rejected Sanofi’s request to bring its dengue vaccine to market without data from locally run Phase III trials. The ruling by the health apex committee follows positive responses from two other panels, which felt the waiving the requirement for a local Phase I...
  • New Legislation Aims to Provide FDA with New Authority to Regulate Compounders

    US Rep. Ed Markey (D-MA) plans to introduce a new piece of legislation he says will give the US Food and Drug Administration (FDA) new authority to regulate compounding pharmacies while still preserving state-level oversight authority. Markey's bill, the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012 , is an attempt to rectify a "regulatory black hole" responsible for letting through dangerous products that have killed dozens of patients an...
  • Analysis: Compounding Crisis Leaves Regulators With Few Good Options

    Extensive problems with a compounding pharmacy in Massachusetts have left US regulators in a complicated bind: They can err on the side of caution and shut down the company's sister organization until it receives regulatory approval, but doing so would likely exacerbate drug shortages already near record highs thanks to similar shutdowns related to regulatory deficiencies in larger pharmaceutical establishments. The owners of the New England Compounding Center (NECC), th...
  • Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

    What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy. The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus fa...
  • Regulators Scramble to Contain Compounding Crisis as Industry Scrutinized

    • 16 October 2012
    • By
    The US Food and Drug Administration (FDA) continues to warn consumers and healthcare providers about drugs manufactured by the New England Compounding Center (NECC), saying two additional drugs could be contaminated with dangerous types of fungus. ( Regulatory Focus ) - FDA has warned of two additional drugs potentially infected with either fungal meningitis or aspergillus fumigatus , possibly widening the pool of patients affected by drugs compounded at NECC. The a...
  • FDA Identifies Two Additional Compounded Drugs as Potentially Contaminated

    The US Food and Drug Administration (FDA) issued a statement on 15 October indicating two additional products manufactured by the New England Compounding Center (NECC) could be contaminated by fungal meningitis, further exacerbating an already complex crisis. In its statement, FDA said it was aware of at least one patient potentially associated with an epidural injection of triamcinolone acetonide and two transplant patients who received a cardioplegic solution who hav...
  • Compounding Crisis Continues as Reports Raise Questions of Quality

    • 15 October 2012
    • By
    US regulators continue to scramble to understand the extent of a meningitis outbreak linked to a compounding pharmacy in Massachusetts as the death and infection count continue to rise day by day-an unfortunate side effect of a disease with an incubation period that can last months. ( Reuters ) - The Centers for Disease Control and Prevention has confirmed more than 15 deaths and 200 cases of meningitis from steroid injections manufactured by the New England Compounding ...
  • House Democrats Take Aim at FDA, Call for Agency to Release Information

    The US Food and Drug Administration (FDA) is increasingly finding itself at the center of a burgeoning crisis involving steroid injections compounded by a Massachusetts pharmacy that have so far killed 12 and sickened dozens with meningitis. Two prominent members of the US House of Representative's Energy and Commerce Committee-the House's legislative vehicle for overseeing FDA and the pharmaceutical industry-have aimed their sights squarely on FDA, calling on the agen...
  • As Compounding Crisis Widens, Legislators Propose Regulatory Fixes

    US legislators are scrambling to get to the bottom of a burgeoning crisis involving products compounded at a Massachusetts pharmaceutical compounder's facility that have thus far killed 11 people and infected more than 100, announcing hearings and new legislation meant to plug oversight gaps in the regulatory system. In a 9 October announcement , the House Energy and Commerce Committee said it had requested briefings from both the US Food and Drug Administration (FDA) a...
  • UK Regulator: Don't Overreact to PIP Scandal

    The head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, said modest improvements are necessary to correct deficiencies exposed during the Poly Implant Prothese scandal . In remarks made at a press conference on 16 February, Woods called for "better surveillance and reporting of any problems with medical devices on the market, and more coordination between national medical regulators," wrote Reuters . Woods added that while he t...
  • EC Investigation of PIP Implants Inconclusive, Calls for Further Study

    A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP's breast implant products. The study, released 2 February 2012, calls for additional investigation, surveillance of the products and stress tests on the products. The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) conducted the stud...
  • After Drug Deaths, Calls for Pakistan to Form Independent Drug Regulatory Authority

    Pakistan is facing calls from industry for a drug regulatory authority to be formed after a batch of cardiac drugs given to patients at a government-run hospital has been linked to more than 100 deaths. Patients at the Punjab Institute of Cardiology were given one or more drugs manufactured by relatively small, local companies . The drugs, given to roughly 40,000 patients, generated side effects that were initially confused with dengue fever. Almost 250 patients remai...