Tag Archives: FDA

Movies for regulatory professionals: Dallas Buyers Club (2013)

This is a movie I found especially interesting and enjoyable as a regulatory affairs professional, both because of the historical perspective, and because of the ethical and philosophical exercise of thought it brings. Dallas Buyers Club is a 2013 American biographical … Continue reading

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Americas Health Authorities Meeting

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in … Continue reading

Posted in Argentina, Brazil, Canada, Colombia, Cuba, Mexico, Uncategorized, USA | Tagged , , , , , , , , , , , , , , , , , , , , , | 2 Comments

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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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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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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