Regulatory

Health Canada has put all Drug Establishment License (DEL) holders on alert as to their regulatory responsibilities and obligations for maintaining good manufacturing practices (GMP).  In addition to increasing the frequency of planned and unplanned inspections of pharmaceutical manufacturing plants, Health Canada now offers a routinely updated and publicly available online tool for tracking the latest regulatory actions against drug manufacturing companies.  The “Inspection Tracker: Drug Manufacturing Establishments” provides a “snapshot of the potential health and safety issues that Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute, or import drugs for sale in Canada.”   In response to allegations of inadequacy and secrecy, Health Canada has now made available the results of its pharmaceutical manufacturing plant inspections since 2012.

Source:  Toronto Star,  6 March 2015

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The FDA has published an updated Guidance Agenda – new and revised draft guidances CDER is planning to publish during calendar year 2012.   Guidances of particular interest to nonclinical pharmaceutical toxicologists may include:

Pharmacology/Toxicology

• Endocrine Disruption Potential of Drugs: Non Clinical Evaluation

Procedural
• Integrated Summary of Safety

Biopharmaceutics

• Food-Effect Bioavailability and Fed Bioequivalence Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New Drug Applications General Consideration

Electronic Submissions
• Providing Regulatory Submissions in Electronic Format – General Considerations
• Providing Regulatory Submissions in Electronic Format – Study Data
• Providing Regulatory Submissions in Electronic Format – Standardized Study Data

 

SourceU.S. Food and Drug Administration

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Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research).  The presentation includes review times and comparison to global approvals.  Of note, median approval times for New Molecular Entities (NME) applications are 10 months, a 47% reduction from calendar year 1993.  A status update on CDER compliance with past PDUFA goals is given, with information on forward planning to comply with PDUFA V goals.  In accordance with the enhanced emphasis on benefit-risk analysis in PDUFA V, discussion of the anticipated framework and balance of stakeholder concerns is detailed.   The PDUFA V program for NME review is presented, with key elements and projected timelines detailed.

This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.

Source Slide Show (pdf hyperlink):  FDA

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FDA Pharamacogenomic Biomarker Database

Posted by cdavenport on Thursday Jul 5, 2012 Under Databases, Drug Safety, FDA, Genetic Toxicology, Regulatory

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe:

    • Drug exposure and clinical response variability
    • Risk for adverse events
    • Genotype-specific dosing
    • Mechanisms of drug action
    • Polymorphic drug target and disposition genes

This resource table lists FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.

Source:  FDA

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FDA Resource for Approved Drug Information

Posted by cdavenport on Monday Jun 25, 2012 Under Databases, FDA, Preclinical, Regulatory

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?

By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products.  The database includes most of the drug products approved since 1939 and has drug labels, patient information, approval letters, and other information for most drug products approved since 1998.

Source:  FDA

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Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data.  A new study, funded by the Pew Charitable Trusts (to be published in the New England Journal of Medicine), reviewed drug approval decisions of the Food and Drug Administration (FDA), the Canadian drug regulator -Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010.  Yale and Mayo Clinic researchers studied each regulator’s database of drug approvals to identify novel therapeutics and timing of key regulatory events, thereby allowing regulatory review speed to be calculated.  The study found that the FDA approves 80% of all the applications it receives.  The median time for novel drug reviews by the FDA was 322 days (10.5 months).  That was 45 to 70 days ahead of Europe and Canada, which typically completed their novel drug reviews after 12 and 13 months, respectively.  Over the same 10-year time frame, the FDA reviewed 225 novel drug applications, 40 more than Europe and nearly 125 more than Canada.  Among novel drugs approved in both the U.S. and Europe, 64% were first approved by the FDA.  For novel drugs approved in both the U.S. and Canada, 86% were first approved by the FDA.

Release of study results may be too late to impact upcoming drug user fee Congressional legislation.  This legislation will reauthorize user fees the FDA collects from companies that make prescription drugs and medical devices.   In return for a 6% increase in user fees, the FDA has already agreed to accelerate novel drug approvals even further.  The standing Senate bill (approved by the White House) supports a new user fee for the review of generic drugs and adds provisions that address some challenges of globalization by enhancing the safety of the drug supply chain, increase incentives for the development of new antibiotics, renew and enhance mechanisms to ensure that children’s medicines are appropriately tested and labeled, and that expedite the development and review of certain drugs for treatment of serious or life-threatening diseases and conditions (e.g., by allowing conduct of smaller, shorter clinical trials).

SourcesHuffPost Health, Modern Healthcare.com, R&D Magazine, and The Hill.

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High-throughput ADME Screening Technologies

Posted by cdavenport on Monday Apr 16, 2012 Under ADME, Drug Safety, Regulatory

High throughput (HT) Absorption, Distribution, Metabolism, and Excretion (ADME) screening technology is the current push from Big Pharma to be outsourced through contract research organizations (CROs).  Shifting also is the ADME regulatory emphasis; the FDA has released a draft guidance (17 Feb 2012) that includes specific wording around what needs to be done with respect to transporter drug-drug interactions (both efflux and influx).  The guidance will start to drive significant changes in how ADME screening is performed.  Two assays that are routinely being utilized in pharma are the Caco-2 cell-based assay and the PAMPA (parallel artificial-membrane permeation) assay.  As currently practiced, predictive ADME screening is made even more difficult given the variety of transport mechanisms available.  In toxicology screens (ADME-tox), however, one is not looking for altered aspects of the drug, which is generally initially unknown, but changes in known, endogenous parameters.  Thus ADME-tox lends itself more easily to HT platforms.  New platforms for high throughput ADME screening are available, and discussed in this article.

Source:  Drug Discovery and Development

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To make best use of its limited resources, the Institute of Medicine (IOM) concludes that the US Food and Drug Administration (FDA) should direct resources to improve the regulatory systems of developing nations to better ensure the safety of the global pharmaceutical supply chain.  Rather than try to inspect all foreign establishments itself, the FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand are encouraged to plan a system for mutual recognition of inspections, which would eliminate the wasteful duplication of effort.  Along these lines, an active pharmaceutical ingredient (API) inspection program involving many of the world’s premiere global regulatory bodies (FDA, the European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the European Directorate for the Quality of Medicines & Healthcare (EDQM), and the Council of Europe (CE)) has formed to facilitate international collaboration and information sharing to enhance inspection capacity.   Since data review and interpretation is already being shared between some global regulatory authorities in the nonclinical safety arena, it will be interesting to see if such global harmonization efforts extend to nonclinical safety inspections in the near future.

 

Sources: 

RAPS – Regulatory Focus:  IOM – Boost Foreign Regulatory Capacity and  Global API Inspection Scheme

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Nonclinical Toxicology: FDA Guidance Agenda for 2012

Posted by cdavenport on Monday Mar 26, 2012 Under Drug Safety, FDA, Preclinical, Regulatory

The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012.  There are about 50 such guidances planned.  Below are a few select highlights relevant to the preclinical safety space, with emphasis on the drug development of small molecules.

Electronic Submissions

  • Providing Regulatory Submissions in Electronic Format – General Considerations
  • Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions.  Using the eCTD Specifications
  • Providing Regulatory Submissions in Electronic Format – Study Data
  • Providing Regulatory Submissions in Electronic Format – Standardized Study Data

Procedural

  • Integrated Summary of Safety
  • Investigational New Drug (IND) Applications prepared and submitted by Clinical Sponsor Investigators

 

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FDA Pre-IND Meetings: Why, When and How

Posted by cdavenport on Friday Feb 24, 2012 Under FDA, Regulatory, TigerU

The pre-IND phase of drug development is the foundation upon which all development-related activities (including registration) depend.  It is, therefore, essential to give proper forethought and attention to this initial, all-important step of the drug-development process.  In the United States, a pre-IND meeting can add considerable value to the overall process and maximize efficient use of both Sponsor and FDA resources.  Although pre-IND meetings require considerable planning and preparation on the part of both the Sponsor and FDA, if warranted and properly conducted, the meeting can provide the Sponsor with valuable insight as to the FDA’s expectations regarding initial- and later-stage development and registration strategies.  This presentation provides a high-level introduction to U.S. FDA pre-IND meetings ─ why and when a Sponsor should consider having a meeting and how the Sponsor approaches the process.

 

Source: Outsourcing4BioPharma

Outsourcing4BioPharma is designed to facilitate business transactions between the clients in health science industries and the contract service providers.

USA · http://www.outsourcing4biopharma.com

 

About the Author:

Grace Furman, Ph.D.

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