• Harmonization of Quality Groups and Automated Quality Audit Systems

    19 April, 2017 Chris Ball, AMGIT

    The term harmonization has become a buzzword in the life science sector and doesn't just refer to the harmonization of international standards created by various regulatory (or voluntary) bodies but can also refer to the harmonization of company-wide cultural and political differences as well as the harmonization of varying policies and procedures introduced by company mergers and acquisitions.

    Full story
  • Using Good Systems Practice to Right-Size IT Services for Emerging Biotech Firms

    19 April, 2017 Keith Parent and Christopher Port

    By Keith Parent and Christopher Port

    Full story
  • Four 'Dos and Don'ts' for Handling Warning Signs about an Approved Drug

    8 September, 2011 Brian S. Inamine and Michael F. Ruggio, Attorneys and Shareholders, LeClairRyan

    Faced with bad news about an approved drug (e.g. anything from a rise in reports of adverse reactions among patients to FDA notification that a warning letter is in the mail) pharmaceutical companies naturally tend to focus on the crisis at hand: Can this lucrative product stay on the market, or is a recall inevitable? And if the drug can be saved, what can companies do now to help keep it on the market? Such questions must be asked and answered because according to the trade publication, Gold S

    Full story
  • Investigating Clinical Trial Investigators Means More Headache for Drug Sponsors

    18 April, 2017 Michael McCaughan

    One leading indicator of a more enforcement-minded approach at the food & drug administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.

    Full story
  • Pharmaceuticals: Articles / News

    MasterControl

    Full Article

    Full story
  • Pros and Cons of Proposed PDUFA IV User Fee Increase From FDA - For Pharmaceuticals

    MasterControl

    FDA Proposes PDUFA User Fee Increase to Boost Drug Safety

    Full story
  • From Poison Squad to Industry Regulator: A Historical Perspective of the FDA

    18 April, 2017 Robyn Barnes

    It hasn't always been this way. If you take a historical perspective, the FDA has been in the game for nearly 200 years.

    Full story
  • FDA Crisis: An Attrition of Brain Power

    Marci Crane

    If people are an organization's greatest asset, the FDA's current "people status" is one of serious attrition.

    Full story
  • Quality Control - Top Reason For FDA-483 Citations Among Drug Companies

    MasterControl

    If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

    Full story
  • Top Reason for FDA-483 Citations - Pharmaceuticals

    MasterControl

    If you're looking to improve a single area in your FDA compliance initiatives, look no further than your quality control unit (QCU). A report by an official of the Center for Drug Evaluation and Research (CDER) shows that QCU-related issues comprise the Number One reason why pharmaceutical companies receive FDA-483 citations.

    Full story
  • FD&C Amendments at Work in the Pharmaceutical Industry - Are They Working for Your Company?

    18 April, 2017 Marci Crane

    The FD&C (Food, Drug and Cosmetic) Act, initially passed in 1938, has greatly influenced, and continues to influence, the ebb and flow of the pharmaceutical industry. The FDA also plays a big part in that influence since it is common for the FDA to interpret the Act for executive purposes.

    Full story
  • New FDA Guidance to Balance Risks and Benefits of Drugs

    18 April, 2017 MasterControl

    FDA to Provide Emerging Drug Safety Information

    Full story
  • All New Electronic Submissions Must Conform to eCDT format - For Pharmaceutical Industry

    18 April, 2017 Lane Hirning

    For well over a decade, there has been an initiative by the International Conference on Harmonization (ICH) to standardize formats for new drug applications in the U.S., Europe, and Japan (where the majority of new medicines are developed).  In the past, the format and organization of submissions varied by country, which made it difficult and time-consuming for a U.S. drug company, e.g., to submit an application for drug approval in Japan or the United Kingdom, and vice versa. A com

    Full story
  • Three Steps to Improved Compliance Management - Pharmaceutical Industry

    Dave Richardson, Senior Analyst, Cutting Edge Information

    It's no secret that pharmaceutical companies have great concerns about their overall compliance efforts. In fact, in several conversations that I've had with executives from marketing, sales, clinical, medical and other functions, it's rare to hear that compliance isn't a hot-button issue.

    Full story
  • At the Heart of Clinical Research: The Protocol

    18 April, 2017 Rebecca Daniels Kush

    The protocol is core to every clinical research study; it is the plan. The protocol is used in designing the study, selecting investigative sites, developing the data collection tools, describing the study procedures and the analysis plan. Institutional Review Boards (IRBs) or Ethics Committees use the protocol as the basis for approving whether a study can be initiated. A well-constructed protocol can ensure common understanding of the study objectives and procedures to be implemented, there

    Full story
  • CHANGING TRENDS: Clinical Research Personnel Qualifications!

    Liz Wool, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc.™

    In the last decade, clinical researchers have conducted clinical trials where their lack of knowledge of human subject protections embodied in Good Clinical Practices and ethical conduct for research (Belmont Report, Declaration of Helsinki) has resulted in clinical trial misconduct and subject deaths. Notably, these cases were reported in both our news media and professional publications.

    Full story
  • How Will the FDA's New Clinical Investigations Guidance Affect Pharmaceutical Companies?

    18 April, 2017 MasterControl

    Discusses how the FDA?s new clinical investigations guidance will positively affect pharmaceutical companies in light of recent news on the relationship between FDA and the industry

    Full story
  • FDA's Evolving Civil Money Penalty Authority:Simple Violations Can Lead to Major Costs

    18 April, 2017 Vernessa Pollard, Counsel in the FDA and Healthcare group at Arnold & Porter LLP, and Mahnu Davar, Associate in the FDA and Healthcare group at Arnold & Porter, LLP

    The U.S. Food and Drug Administration (FDA) has several enforcement tools at its disposal, including warning letters, injunctions, seizures and criminal prosecutions. While most industry professionals are familiar with these enforcement tools, FDA's civil money penalty (CMP) provisions may be less familiar to some. In the past five years, CMPs have emerged as an important enforcement tool as Congress has increasingly expanded FDA's authority to impose such penalties. With the expansion of FDA

    Full story
  • Five Essential Elements of Computerized Systems Used in Clinical Trials

    18 April, 2017 MasterControl

    In a recent statement announcing the FDA’s partnership with Duke University aimed at modernizing clinical trials, Janet Woodcock M.D.—the FDA’s deputy commissioner, chief medical officer, and leader of the Critical Path Initiative—stressed the importance of technological advances in clinical trial processes. “To ensure the safety of clinical trial participants and to improve the health of the public, the clinical research enterprise needs to evolve,” D

    Full story