• Feature ArticlesFeature Articles

    Visualizing Data

    This article discusses the history of making data visual and suggest ways to keep viewers of visual data engaged. The author offers thoughts on software programs and books that may serve as good sources for learning more about visual data presentation. Introduction As part of management review, teaching, panel meetings, budgets or during an inspection by notified bodies or regulatory agencies, regulatory affairs personnel are frequently called upon to provide data to di...
  • Regulatory NewsRegulatory News

    Data Integrity Q&A: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...
  • Regulatory NewsRegulatory News

    FDA Tweaks Final Guidance for PMAs and Device BLAs

    The US Food and Drug Administration (FDA) made minor revisions to a 2017 final guidance on Wednesday on user fees and refunds for premarket approval applications and device biologics license applications.   The minor revisions to the final guidance, issued in October 2017, merely incorporated information on device biologics license applications from a superseded guidance.   Portions of FDA’s previous guidance on assessing user fees were superseded by the “ Bundli...
  • Regulatory NewsRegulatory News

    CBO Offers Positive Score for Senate Bill to Reform OTC Drug Regulations

    The Congressional Budget Office (CBO) this week said that a Senate bill that would create a new user fee program for over-the-counter (OTC) drugs would not increase the budget deficit. “Over the 2019-2023 period, spending would lag collections by $10 million,” CBO said . Elizabeth Jungman, Pew’s director of public health programs, told Focus : “The CBO score seems like a sign that things are moving in the right direction. Hundreds of millions of Americans use OTC p...
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    TGA Clarifies SaMD Policies, Signals Changes to Classification Regulations

    Australia’s Therapeutic Goods Administration (TGA) released new guidance on the regulation of software as a medical device (SaMD), with plans to change SaMD classification.   The guidance clarifies the types of software and mobile applications that fall within the scope of the SaMD regulation based on the definition of a medical device. These include “smart phone apps that calculate insulin doses based on a patient's blood glucose levels” and software that uses “inform...
  • ReconRecon

    Recon: Lilly, AC Immune Partner on Alzheimer’s Treatment; FDA Rejects Mallinckrodt’s Abuse-Deterrent Opioid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA declines to approve Mallinckrodt's abuse-deterrent opioid painkiller ( Reuters ) ( Endpoints ) Lilly partners with AC Immune for Alzheimer's treatment ( Reuters ) ( BioCentury ) ( Fierce ) ( Endpoints ) Kaleo, maker of $4,100 overdose antidote, authorizes a generic version for just $178 ( STAT ) ( The Hill ) This Killer Opioid Could Become a Weapon of Mass...
  • Regulatory NewsRegulatory News

    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance for industry discussing the recommended components of a biomarker development program, including how to determine the type and level of evidence sufficient to support qualification, and how these components interrelate to inform an evidentiary framework. The draft comes as to date, FDA has qualified eight biomarkers and received 29 submissions . Still, as the draft notes, progress in biomark...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections

    New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections   Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine earlier this year and stuck with their decision despite respondents objecting to the reclassification ruling and how it was reached.   The New Zealand Medicines and Medical Devices Safety Author...
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    FDA Warns China’s Zhejiang Huahai Over Failures to Detect Impurities in Valsartan API Batches

    China-based Zhejiang Huahai Pharmaceuticals drew a US Food and Drug Administration (FDA) warning letter over failures to conduct investigations into impurities classified as probable human carcinogens. The warning letter is FDA’s latest move in its ongoing review of the potential impact of two impurities on batches of valsartan active pharmaceutical ingredients (API). Zhejiang Huahai has been at the center of the international drug safety issue since certain valsartan-c...
  • Regulatory NewsRegulatory News

    House Floats Five Year Extension of Medical Device Tax

    The widely unpopular medical device excise tax would be delayed for another five years under a tax relief package introduced by the US House Ways and Means Committee on Monday. The 2.3% levy on the sale of prescribed medical devices was in effect between 2012 and 2014 after it was enacted through the Affordable Care Act in 2010, but the pushback from industry has led to several moratoriums. It received a 2-year delay extension earlier this year as part of a continuing r...
  • Feature ArticlesFeature Articles

    Safety First

    This article reviews the development of global Good Distribution Practices (GDPs) against the background of an increasingly complex pharmaceutical supply chain, five years after the initial implementation of the extended EU GDP Guideline. Introduction On 5 November 2018, the current EU GDP Guideline turned five years old. 1 What have we learned in those five years? Have we succeeded in achieving a better protection of the integrity of pharmaceutical products and for...