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Latest News | 4 March 2014

Regulatory Reconnaissance: High Costs of Ultra Orphan Drug Concern UK Regulators (4 March 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Do you work in regulatory Read More...


Latest News | 3 March 2014

Dosing Recommendations in Patients with Kidney Damage Focus of Revised EMA Guideline

The European Medicines Agency (EMA) has released for consultation a new guideline on assessing the preclinical safety of products intended to be used by patients with decreased renal function.The Read More...


Latest News | 3 March 2014

Can FDA and Industry Give Patients and Providers the Evidence They Need to Make Informed Decisions?

The US Food and Drug Administration (FDA) soon plans to hold a hearing on the extent to which historically under-represented subgroups of patients are included in clinical trials, and whether their Read More...


Latest News | 3 March 2014

Regulatory Reconnaissance: Pfizer Seeks FDA Approval for OTC Lipitor (3 March 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Do you work in regulatory Read More...


Latest News | 28 February 2014

FDA Releases Guidance on Use of Scientific and Medical Literature for Promotional Purposes

A new draft guidance document released by the US Food and Drug Administration (FDA) aims to clarify the ways in which a pharmaceutical or medical device manufacturer may use scientific and medical Read More...


Latest News | 28 February 2014

Regulatory Reconnaissance: FDA Approves More Versions of Generic Plan B One Step (28 February 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Do you work in regulatory Read More...


Latest News | 27 February 2014

Gates Foundation Says New Efforts Needed to Bolster Pharmacovigilance Systems in Developing World

A new report just released by the Bill and Melinda Gates Foundation calls for an expansion of pharmacovigilance efforts in low- and middle-income countries (LMICs) to ensure the safety of healthcare Read More...


Latest News | 27 February 2014

FDA 'Pay-to-Play' Scandal Drags on as Senators Press Agency, Academics for Details

In October 2013, The Washington Post and MedPage Today both broke stories regarding a so-called "pay-for-play" deal in which some members of the pharmaceutical industry had paid hefty sums to attend Read More...


Latest News | 27 February 2014

New FDA Guidance Clarifies Standards for Submission of HIV-1 Virology Data

A new guidance document released by the US Food and Drug Administration (FDA) intends to clarify the agency's recommended approach for submitting resistance data for drugs intended to treat Read More...


Latest News | 27 February 2014

Health Groups Applaud Legislation to Create New FDA Approval Pathway, But Offer Suggestions

In December 2013, legislators introduced a new piece of legislation that would permit the US Food and Drug Administration (FDA) to approve antibiotic drugs for high-need sub-populations using less Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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