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How Safe Are Biosimilars?
Implications of FDA and EMA Guidances and European Experience since 2006
Part one of a two-part series on the pre- and postapproval clinical safety of known EU-approved biosimilar therapeutic protein medicinal products. Read more

ClinicalTrials.gov: Requirements and Implementation Strategies
Key considerations, helpful hints and some lessons learned to help you meet the requirements of FDAAA as well as the trial registration policy of the ICMJE. Read more

Demystifying Electronic Data Standards for Clinical and Nonclinical Studies
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. Read more

Bloodletting and Malariatherapy: Treatment Methods of the Past
Those interested in the history of medicine should read the details surrounding the therapy rendered to President George Washington by his physicians in December 1799. Read more

Regulatory Environment Changes Affect REMS
A recent guidance (November 2011) reduced the need for a REMS when a medication guide is the only REMS element. Read more

Perspective: A Modern Progressive Approval System for Rare Diseases
The recent dramatic increase in the number of orphan drug designations has prompted many stakeholders to look for ways to accelerate the delivery of innovative new medicines to people with rare diseases... Read more

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Science and Technology | 26 April 2012

Bloodletting and Malariatherapy: Treatment Methods of the Past

Those interested in the history of medicine should read the details surrounding the therapy rendered to President George Washington by his physicians in December 1799. This article explores purging, bloodletting and other methods employed to help treat Washington, which actually hastened his death.

Perspective | 16 April 2012

A Closer Look at Strategic Alliances Between Drugmakers and CROs

Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. Read more »

Under RAPS | 17 May 2012

Considering Risk Evaluation and Mitigation Strategies (REMS)

Every drug comes with some risk. The key issue for regulators, drugmakers, healthcare professionals and patients alike is whether the likely benefit is greater than the risk. This is the question reviewers at the US Food and Drug Administration (FDA) must grapple with in determining whether or not to approve a new product or to leave an already approved product on the market in light of new information about adverse events or other potential negative consequences. In some cases, additional conditions need to be put in place to help manage a drug product’s risk.

Under RAPS | 14 May 2012

Next RAPS Virtual Career Fair: 17 May

The Regulatory Affairs Professionals Society (RAPS) will host its next Virtual Career Fair on Thursday, 17 May, from 10 am–6 pm EDT. RAPS members can enter the fair at 9 am—one hour ahead of the general public—to gain exclusive access to recruiters.

Regulatory Update

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Brazil: New Bioanalytical Standard Published

Posted: 24 May 2012
Brazil’s national regulatory agency, Anvisa, has published a new standard (RDC 27/2012) setting forth the minimum requirements for conducting the bioanalytical method validation studies needed for the Read more »

UK: Chair Appointed for UK’s New Emerging Science and Bioethics Advisory Committee

Posted: 23 May 2012
The Chair of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Sir Alisdair Breckenridge, has been appointed the first Chair of the newly established Emerging Science and Bioethics Read more »

World: Regulatory Agencies Attend WHO Seminar

Posted: 21 May 2012
Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate.The meeting, an international Read more »

Brazil: Anivsa Sets Confidentiality Criteria

Posted: 21 May 2012
A notice (Ordinance No. 748-B/2012) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access Read more »

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Regulatory Exchange

Join the discussion -- RAPS Regulatory Exchange

RE:Seeking EU Device Directives Expert
Posted: 5/21/2012 10:20:28 AM
From : Discussion Post>>Regulatory Open Forum
I have received numerous responses to this post and am now going through bios to contact potential SMEs for this project or other potential course reviews. Thank you for the overwhelming response. -------------------------------------------...

RE:Measuring Submissions
Posted: 5/19/2012 11:37:10 AM
From : Discussion Post>>Regulatory Open Forum
It seems like the type of the measurements you want to track willdepend on your purpose in tracking them. For example, if you are looking for quality metrics to improve your inhouse process, I'm doubtful that tracking the branch and reviewe...

CDER Small Business Newsletter statement on eCTD
Posted: 5/18/2012 10:25:10 AM
From : Discussion Post>>Regulatory Open Forum
From the FDA/CDER Small Business Chronicles issue dated May 10, 2012, subject IND 101: "Although CDER still accepts paper IND submissions, we strongly encourage sponsors to present INDs in the electronic common technical document (eCTD) for...