• DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

    The US Food and Drug Administration (FDA) is getting some new, though not unexpected, authority this week by way of its parent organization, the US Department of Health and Human Services (DHHS). The new authority pertains to a new law passed in 2013 known as the Drug Quality and Security Act (DQSA) , which was passed in the wake of a deadly scandal involving pharmaceutical products compounded using deficient practices. Part of the law permitted FDA to more tightly r...
  • CDRH Cedes Regulatory Authority for Certain Wound Care Products to CBER

    If you're the sponsor of a wound care product, you may soon be dealing with a new set of regulatory staff at the US Food and Drug Administration (FDA), the agency announced in the Federal Register on Tuesday. The 13 August 2013 announcement explains that FDA is "transferring oversight responsibilities for certain wound care products" from the Center for Devices and Radiological Health (CDRH), where some new reside, to the Center for Biologics Evaluation and Research (C...
  • Brazilian House Holds Hearing on Anvisa Regulatory Authority

    The Committee on Social Security and Family of Brazil's House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil's National Health Surveillance Agency (Anvisa) with one question in mind: Does Anvisa have too much regulatory authority? The deputy director of Anvisa, Neilton Araújo, argued that several bills introduced in the Brazilian Congress to cut back the agency's regulatory authority would in fact be a setback for ...
  • FDA Given New Authority to Oversee Clinical Trials Data Reporting

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement . Under section 801 of the Public Health Service Act (PHSA) , as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institut...
  • Legislators Slam DHHS, FDA for Special Hiring Practices

    The US Food and Drug Administration (FDA) has increased its use of special hiring authorities more than 50% in recent years to bring on staff members who can be paid more than the normal limit for federal employees, and some legislators are none too pleased at the trend. In a 14 September 2012 hearing, the Government Accountability Office (GAO), which earlier released a report on the topic , testified that the Department of Health and Human Services' (DHHS) use of speci...
  • Hamburg Continues to Call for More Anti-Counterfeiting Authority

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg remains adamant the agency needs more authority to go after counterfeiters . For the third time in as many months, Hamburg has spoken out publicly in an attempt to garner more attention for what she sees as a lack of legal and regulatory "teeth" to address the problem of fake and substandard drugs entering the US' pharmaceutical supply chain. Speaking on Wednesday, 7 June to The Financial Times , Ham...
  • Hamburg: FDA Needs More Anti-counterfeit Authority, International Track and Trace Cooperation

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said the agency needs more authority to deal with counterfeit drug products like the fake Avastin that found its way into the supply chain last month. Speaking with CNN , Hamburg noted the fake Avastin has "focused new attention and concern on counterfeit drugs," which she hopes will make it easier to work with Congress. "They're considering some legislation that would give the FDA stronger authority...
  • Implementation of Medical Device Recall Authority Sought by FDA

    The US Food and Drug Administration (FDA) announced on 10 February that it is seeking to implement its medical device recall authority under § 518(e) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and Chapter 21, Section 810 of the Code of Federal Regulations (CFR). Section 518(e) allows FDA to order manufacturers to cease distribution of a device and notify health professionals if FDA finds a "reasonable probability that the device intended for human...