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FDA considers prescription drug switch to OTC - Cardiology Today

FDA considers prescription drug switch to OTCCardiology TodayThe FDA held a public hearing to obtain information and comments from the public on the feasibility of a new paradigm that would allow certain drugs for nonprescription use and its...
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Sanofi demande l'AMM pour un nouveau Vaxigrip® quadrivalent - Le Généraliste (Abonnement)

Sanofi demande l'AMM pour un nouveau Vaxigrip® quadrivalent - Le Généraliste (Abonnement) | market access | Scoop.it
Sanofi demande l'AMM pour un nouveau Vaxigrip® quadrivalent
Le Généraliste (Abonnement)
Sanofi demande l'AMM pour un nouveau Vaxigrip® quadrivalent.
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L'Ansm fait le point sur les derniers dossiers examinés par le CHMP ...

L'Ansm fait le point sur les derniers dossiers examinés par le CHMP ... | market access | Scoop.it
Au cours de la séance du 22 novembre 2012, la Commission d'AMM de l'Agence nationale de sécurité du médicament et des produits de santé (Ansm) a fait le point sur des dossiers examinés par le CHMP, comité ...
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FDA Is Asked To Remove Novo Nordisk Diabetes Drug From Market - Wall Street Journal

FDA Is Asked To Remove Novo Nordisk Diabetes Drug From Market - Wall Street Journal | market access | Scoop.it
Updated NewsFDA Is Asked To Remove Novo Nordisk Diabetes Drug From MarketWall Street JournalThe FDA doesn't comment on petitions pending before the agency, and typically takes months or years to respond to such petitions.
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How can you exploit successful market access strategies ... | ONE Resource for HEOR

How can you exploit successful market access strategies ... | ONE Resource for HEOR | market access | Scoop.it
This is an article about exploiting successful market access strategies in pharma and how to ensure patients receive improved treatments by leveraging value.
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Republicans Urge FDA & FCC to Move Faster on mHealth App ...

Republicans Urge FDA & FCC to Move Faster on mHealth App ... | market access | Scoop.it
In a rather interesting move, it's been revealed that Republican House members are urging both the FDA and FCC to move faster in approving mobile medical.
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Europe: EMA Releases New 'Practical Guidance' on Foreign Clinical Trials > RAPS > News - Article View

Europe: EMA Releases New 'Practical Guidance' on Foreign Clinical Trials > RAPS > News - Article View | market access | Scoop.it
The European Medicines Agency (EMA) yesterday (16 April) published guidance, in the form of a final reflection paper, on ethical and good clinical practice (GCP) aspects of clinical trials conducted, (RT @RAPSorg: Europe: #EMA Releases New 'Practical...
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EMA calls for open access to clinical trial data after Tamiflu concerns - PMLiVE

EMA calls for open access to clinical trial data after Tamiflu concerns - PMLiVE | market access | Scoop.it
EMA calls for open access to clinical trial data after Tamiflu concernsPMLiVEThe article's authors, including the European Medicines Agency's (EMA) executive director Guido Rasi and its senior medical officer Hans-Georg Eichler, said that clinical...
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Doctors Pressure FDA for Nonprescription Birth Control Pills - San Francisco Chronicle

Doctors Pressure FDA for Nonprescription Birth Control Pills - San Francisco Chronicle | market access | Scoop.it
Doctors Pressure FDA for Nonprescription Birth Control PillsSan Francisco ChronicleAmid an election campaign that has at times focused on women's health, and fewer than four months after the Obama administration overrode the FDA's support for expanding...
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looks like a nice portal on pharma pricing and market access

Pharma pricing and market access information. Obtain a competitive edge today, with pharmaceutical pricing and reimbursement case studies and best practice.
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L'envolée du coût des médicaments ciblés - Figaro Santé

L'envolée du coût des médicaments ciblés
Figaro Santé
«Les discussions sont en cours avec le Comité économique des produits de santé (CEPS)», répond pudiquement Pierre-Henri Patin, le directeur général de Vertex Pharmaceuticals France.
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Consumer group says Novo Nordisk injection should be withdrawn due to cancer ... - Washington Post

Consumer group says Novo Nordisk injection should be withdrawn due to cancer ... - Washington Post | market access | Scoop.it
Consumer group says Novo Nordisk injection should be withdrawn due to cancer ...Washington PostCiting internal agency documents, the group notes that FDA approved the drug in 2010 against the recommendation of three staff scientists.
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Euroalert.net - The European Medicines Agency published a guide to assure ethical standards in the conduct of clinical trials - News about the European Union

Euroalert.net - The European Medicines Agency published a guide to assure ethical standards in the conduct of clinical trials - News about the European Union | market access | Scoop.it
RT @EU_eHealth: EMA: guide to assure ethical standards in the conduct of clinical trials http://t.co/dlsv8j6M via @Euroalert | @DigitalAgendaEU...
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Sens. Richard Burr and Tom Coburn Introduce a New Plan to Reform the FDA - Forbes

Sens. Richard Burr and Tom Coburn Introduce a New Plan to Reform the FDA - Forbes | market access | Scoop.it
Sens. Richard Burr and Tom Coburn Introduce a New Plan to Reform the FDAForbesUS Food and Drug Administration (FDA) Commissioner Margaret Hamburg speaks during the Daily Press Briefing in the Brady Briefing Room of the White House in Washington,...
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BIO Submits Comments on FDA Draft Guidances on Biosimilars | BioPortfolio.com

BIO Submits Comments on FDA Draft Guidances on Biosimilars | BioPortfolio.com | market access | Scoop.it
From BioPortfolio: The Biotechnology Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on b...
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eCTD Regulatory Submissions Network

eCTD Regulatory Submissions Network | market access | Scoop.it

market access intelligence site

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New FDA Guidance on Benefit-Risk Determination in Medical ...

New FDA Guidance on Benefit-Risk Determination in Medical ... | market access | Scoop.it
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of diagnostic and therapeutic medical devices are considered during ...
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FDA considers prescription drug switch to OTC - Cardiology Today

FDA considers prescription drug switch to OTCCardiology TodayThe FDA held a public hearing to obtain information and comments from the public on the feasibility of a new paradigm that would allow certain drugs for nonprescription use and its...
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Réglementation des IMPLANTS et DISPOSITIFS: La FDA saura-t-elle ... - santé log

Réglementation des IMPLANTS et DISPOSITIFS: La FDA saura-t-elle ... - santé log | market access | Scoop.it
santé logRéglementation des IMPLANTS et DISPOSITIFS: La FDA saura-t-elle ...santé logL'idée serait, pour l'Agence FDA de pouvoir garantir le même niveau de sécurité mais avec plus de rapidité.
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