• Regulatory NewsRegulatory News

    From 100 Hours to 1: FDA Dramatically Simplifies its Compassionate Use Process

    In response to repeated criticism that terminally ill patients find it too difficult to obtain access to experimental and potentially life-saving drugs, the US Food and Drug Administration (FDA) has announced changes to its "compassionate use" process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients. Background FDA's "compassionate use" process—formally known as its Expanded Access Program—is meant to allo...
  • Regulatory NewsRegulatory News

    FDA Proposes Changes to its Adverse Event Reporting Forms

    The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B. Background FDA has three adverse event reporting forms it uses to collect information about medical products, including drugs (prescription and non-prescription), biologics, medical devices and dietary supplements. Form 3500, which healthcare providers can use to report information on a voluntary basis ...
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    The Top 15 Biologics Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of biologics manufacturing facilities, indicating the most common issues faced by biologics companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 146 Form 483s—forms indicating areas of noncompliance at a facility—to biologics companies in fiscal year 2014. T...
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    The Top 15 Pharmaceutical Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of pharmaceutical facilities, indicating the most common issues faced by pharmaceutical companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 645 Form 483s—forms indicating areas of noncompliance at a facility—to pharmaceutical companies in fiscal year 2014. ...
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    The Top 15 Medical Device Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 972 Form 483s—forms indicating areas of noncompliance at a facility—to medical device companies in fiscal year 2014. ...
  • 'Questionable' Documentation Practices Lead FDA to Issue Form 483 to Biogen Idec

    The US Food and Drug Administration (FDA) has released the text of a Form 483 sent to biopharmaceutical manufacturer Biogen Idec, outlining a series of alleged deficiencies affecting the manufacture of two of the company's multiple sclerosis drugs, Tysabri (natalizumab) and Avonex (Interferon Beta 1a). FDA issues Form 483s if, during the course of an inspection of a manufacturing facility, its inspectors find deficiencies in need of addressing. If the issues are serious ...
  • Pharmacy's Penicillin Manufacturing Problems Relate to Recently-Released Guidance Document

    Guidance documents, as the US Food and Drug Administration (FDA) often reminds industry, are not legally binding entities. Rather, they represent insight into regulators' current best thinking on a particular subject, giving companies the opportunity to make compliant their operations and avoid any regulatory headaches. But just because they're not legally enforceable on their own doesn't mean that FDA isn't interested in taking action in accordance with the regulations ...
  • Spiders, Non-Sterile Practices Lead to Warning for Compounder at Center of Recall

    Several weeks ago, US regulators announced that supposedly sterile products manufactured by a Tennessee compounding pharmacy were contaminated with fungus and bacteria, leading to a recall of the company's products and raising troubling parallels between the case and another one that killed dozens and left hundreds seriously injured. Now the US Food and Drug Administration (FDA) has released the details of its inspection of that compounders' facility, revealing disturbing...
  • Facing Major Repercussions from Bad Inspection, Impax Doubles Down on Compliance

    Pharmaceutical manufacturer Impax Laboratories has announced the formation of a new Compliance Committee it says will be focused on providing oversight for the company's regulated activities after the US Food and Drug Administration (FDA) identified major deficiencies at one of the company's manufacturing facilities. Background: Generic Issues Impax is coming off something of a tumultuous period. On 15 March 2013, FDA announced it would withdraw approval for the compan...
  • Device Inspections, Deficiencies Skyrocket for Device Firms Since 2008

    The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device consultancy Emergo Group shows that the agency is dramatically ramping up the number of quality-related deficiencies it cites in its inspection reports. Background FDA has long maintained that it has seen a troubling increase in the number of quality-related deficiencies durin...
  • Compounding Pharmacy Chain Hit with Record Six Form-483s

    Many pharmaceutical companies spend considerable time, resources and energy to ensure that their facilities are in top shape, wary of the potential for US regulators to issue a Form-483 identifying deficiencies at a manufacturing facility and the costs associated with correction or remediation. But if the prospect of just one Form-483 is enough to keep some regulatory affairs professionals awake at night, it's hard not to wonder how much sleep the compliance officials a...
  • Compounding Pharmacy Recalls all Products after FDA Finds Microbial Contamination in Vials

    The US Food and Drug Administration (FDA) has announced that yet another compounding pharmacy has initiated a national recall for all products manufactured at a Florida facility, explaining that an inspection of the facility last month found deficient practices that might have exposed its sterile products to microbial contamination. Background Compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without havi...