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22 May 2012
By Hoss A. Dowlat
This is the first of a two-part series on the pre- and postapproval clinical safety of known EU-approved biosimilar therapeutic protein medicinal products. It compares and contrasts EU experience with the long-awaited, overarching FDA biosimilars guidances. It also anticipates the safety of as-yet-unapproved potential biosimilars, including the recombinant mAbs, insulins, heparins and interferons. Biosimilar medicinal development strategy, perception of general risk, interchangeability, substitution and other aspects of acute or chronic use and first/second line or adjunct therapy are addressed. [
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8 May 2012
By Elaine Wong, MS, and Rebecca Williams, PharmD, MPH
The
Food and Drug Administration Amendments Act of 2007 (
FDAAA) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called
ClinicalTrials.gov. This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research findings. This article discusses key considerations, helpful hints and some lessons learned to help meet the requirements of
FDAAA as well as the trial registration policy of the International Committee of Medical Journal Editors (ICMJE). [
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1 May 2012
By Michelle Conan-Cibotti, PhD, RAC (US, EU)
As part of the
Prescription Drug User Fee Act IV (
PDUFA IV) information technology commitments, the US Food and Drug Administration (FDA) is moving toward a fully electronic, standards-based submission and review environment. FDA has issued a series of guidance documents to assist sponsors in providing regulatory submissions in electronic format. [
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24 April 2012
By Elaine Taylor and Kiley DePolo
One US Food and Drug Administration (FDA) requirement that has undergone an important change is the requirement for inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS). A recent guidance (November 2011) reduced the need for a REMS when a medication guide is the only REMS element. [
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5 April 2012
By Trina Slabiak, MS, RAC and Meredith Brown-Tuttle, RAC
It is important to have the right tools and resources for information about medical device regulations. This article dives into the global regulatory sites by region and describe the addresses you need to know to be able to find medical device information to help put together intelligence and strategy. [
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4 April 2012
By Meredith Brown-Tuttle, RAC
Regulatory Intelligence” (RI) is “the act of gathering and analyzing publicly available regulatory information. This article focuses on sources of regulatory information about drugs.
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3 April 2012
By Kamali Chance, MPH, PhD, RAC
In March 2010, section 351(a) of the
Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products that were found to be highly similar to US Food and Drug Administration (FDA) licensed biologics. This article explores recent FDA guidance pertaining to biosimilar products. [
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30 March 2012
By Grant Ramaley
One of the greatest challenges in discussing standards is trying to put things into context so all those affected can understand why they matter. This article explores how one standard is threatening to undo gains in a vulnerable population. [
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19 March 2012
By Meredith Brown-Tuttle, RAC
Regulatory strategy incorporates the drug development plan, outstanding issues or questions, background information, regulations and/or guidance documents, strategic advice, past precedents (if any) and recommendations on implementation. This article explores the basics of regulatory strategy and how regulatory professionals can best use it.
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9 March 2012
By Meredith Brown-Tuttle, RAC
This article explores some of the author's favorite regulatory intelligence tools and the advantages of each particular source.
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