• Regulatory NewsRegulatory News

    CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements. TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with ...
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    EMA Takes a Firmer Stance on GCP Non-Compliance

    Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA). Stressing the importance of GCP compliance, the EMA says it’s an “essential prerequisite” for assessing a medicinal product’s safety and efficacy. The agency also clarifies that when a study is found to...
  • RAPS' LatestRAPS' Latest

    Compliance: Not Just a US Issue

    “Compliance” might be one of the most frequently-used terms in the healthcare industry. Compliance covers so many things and, in fact, is not merely a US issue. Life science companies must ensure global compliance, and this collection of feature articles in Regulatory Focus exclusively for RAPS members only scratches the surface. In “ Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada ,” Ryan Thompson, Vadim Lysenko, Mukesh Kumar, Giri ...
  • Regulatory NewsRegulatory News

    After Court Rulings, Canada Proposes Changes to Combination Drug Requirements

    Canada is looking to amend its Patented Medicines (Notice of Compliance) Regulations after two high-profile court rulings took a strict interpretation of the regulations that would make it more difficult to protect combination drugs under the regulations. Background In Canada, a notice of compliance is issued to a drug company when its product has been authorized. The requirements for a notice of compliance to be issued can be found in C.08.004 of the Food and D...
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    Compliance is Hard: FDA Warns Company After Finding Cialis Ingredient in its Product

    For one dietary supplement company warned by the US Food and Drug Administration (FDA) this week, regulatory compliance has something in common with what the company claims its "male enhancement" product will do to users: It's hard. Overview The Warning Letter—among the very few we've ever read to include explicit language—calls out Biogenix USA, a Mississippi- and Georgia-based company inspected by FDA in 2013. During the inspection, FDA said it collected "product labe...
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    CDRH Compliance Director Silverman Leaving FDA

    The longtime director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance, Steve Silverman, plans to leave the US Food and Drug Administration (FDA) next week to pursue other opportunities, press officials have confirmed to Regulatory Focus . Silverman has been a central figure in CDRH's " Case for Quality ," an effort to improve compliance among medical device manufacturers by focusing on common quality errors across the device industry. "We...
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    CDER Announces Hire of Top Compliance Official

    The US Food and Drug Administration (FDA) has announced the hire of a new senior official, Cynthia Schnedar, who will serve as the director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), its drug compliance enforcement division. The position had been vacated earlier this year by Howard Sklamberg , who had served as director of CDER's OC since November 2012 . In January 2014, Sklamberg was promoted to the position of deputy commis...
  • Feature ArticlesFeature Articles

    Medical Device Corrective and Preventive Actions

    Medical device companies are required by law 1 to have corrective and preventive action (CAPA) procedures to identify, prevent and correct product quality nonconformities. The effectiveness of a CAPA procedure can make the difference between successfully resolving deficiencies and enduring recurring deficiencies that result in waste, inefficiency, customer dissatisfaction and, potentially, patient-related adverse events. An effective CAPA procedure protects the customer...
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    Comparing Drug Master File Procedures in Highly Regulated Markets

    Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug's identity, strength, purity and quality. The DMF procedure exists all over the world, from highly regulated markets (HRMs) through nearly regulated markets (NRMs). The HRMs, such as the US, EU, Japan, Can...
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    Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations

    The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exh...
  • Feature ArticlesFeature Articles

    The Problem with Audit Reports

    When an audit is conducted, company management expectations are simple: They want to know whether there is a problem, how big it is and whether or not it is being fixed. All too often, audits, and their reflection in follow-up communications, fail to live up to that role because most audit processes and reports fail to take full advantage of, and communicate, the information they gather. Anyone who has been audited has probably heard the phrase: "I'm going to have to wr...
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    Approval of Jakafi (ruxolitinib) Based on a Home-Grown, Patient-Reported Outcome Instrument: A Case Study

    Jakafi® (ruxolitinib) was approved 1 by the US Food and Drug Administration (FDA) on 16 November 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF (PPV-MF) and post-essential thrombocythemia MF (PET-MF). Prior to this time, there were no approved products, and therefore no precedent for regulatory endpoints in this orphan disease. MF is a highly symptomatic 2 myeloproliferative neoplasm (MPN), cha...