Author Archives: Maria I. Guaia

About Maria I. Guaia

Top 10 Pharma – products in the pipeline

Did you know that you can consult which new innovations are in the pipelines of the top 10 pharma companies directly from their websites? Have a look! 1- Johnson&Johnson 2- Pfizer 3- Novartis 4- Sanofi 5- Merck&Co 6- GlaxoSmithKline 7- Abbott … Continue reading

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Anvisa Approves Track and Trace System

Anvisa Approves Track and Trace System.

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List of FDA Advisory Committees

The FDA Advisory Committees for drugs and other healthcare products receive requests for technical and clinical evaluation of new drugs by the U.S. Food and Drug Administration. The committees, consisting of members from academic and clinical settings, the general public, … Continue reading

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Brazil makes proposed outsourcing regulations available for comment

Brazil makes proposed outsourcing regulations available for comment.

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Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry

Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry.

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Mexico at the vanguard with new combination drug

In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in … Continue reading

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Argentina: Site Master File now required by ANMAT for national sites

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading

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Brazil: ANVISA bans Lorcaserin (Belviq)

Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that … Continue reading

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MoU between Mexican and Chinese health authorities

In the framework of the bilateral agreements recently signed by the presidents of Mexico and China, Enrique Peña Nieto and Xi Jinping, respectively, the representatives of both sanitary agencies, subscribed the first Memorandum of Understanding to strengthen cooperation in matters … Continue reading

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Brazil: Overview of API registration

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency. This regulation has been put in … Continue reading

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