• Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • Feature ArticlesFeature Articles

    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (28 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Prepares for Joint National-State Inspections of Manufacturing Plants India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compli...
  • Regulatory NewsRegulatory News

    FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

    The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug ma...
  • Regulatory NewsRegulatory News

    Updated FDA Manual Offers Inside Look at Inspection Protocols

    The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. The 127-page chapter offers the basics for how FDA inspectors should go about conducting what it calls, a "careful, critical, official examination of a facility to determine its compliance with laws administe...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Big Drugmakers Push Back Against Quality Data Requirements in TGA Provisional Approval Plan A who’s who of leading drugmakers have raised concerns about the proposed data requirements for Australia's provisional approval pathway. The concerns center on the potential for the need to provide months of stability data and achieve good manufacturing practice (GMP) clearance...
  • Regulatory NewsRegulatory News

    FDA Details Plans for More Efficient Inspections, Facility Evaluations

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts. In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recent...
  • Regulatory NewsRegulatory News

    Proposed and Final FDA Rules: What’s Left in 2017

    The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings. Proposed Rulemakings Among the proposals coming are rulemakings dedicated to pediatric study plan requirements , internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that a...
  • Regulatory NewsRegulatory News

    EMA Reports Rise in Pharmacovigilance Inspections in 2016

    In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs. Background In the EU, routine pharmacovigilance inspections are typically carried out by national regulators to check that marketing authorization holders have the personnel, systems and facilities in place t...
  • Feature ArticlesFeature Articles

    FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities

    The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs). Introduction Civil and ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Sets Guidelines for FDC Trials as Long Wait for Phase IV Protocols Continues The Drug Controller General of India (DCGI) has outlined how makers of fixed-dose combinations (FDCs) can meet regulatory demands for clinical data on their drugs. DCGI Dr. GN Singh is asking FDC manufacturers to focus on safety data and is providing flexibility in the design of clinical...