The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
Versa Marketing, Inc. Recalls Fusia Szechuan Stir Fry Because of Possible Health Risk
Versa Marketing Inc. of Fresno, CA is recalling 4,089 cases of Fusia Szechuan Stir fry because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA approves Odactra for house dust mite allergies
The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age.
FDA approves Odactra for house dust mite allergies
The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age.
Yoke’s Fresh Market Issues Voluntary Cheese Recall
Out of an abundance of caution and with an emphasis on customers’ wellness and safety, Yoke’s Fresh Market is proactively recalling two types of Colby cheese due to a potential contamination of Listeria monocytogenes.
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FDA approves Xermelo for carcinoid syndrome diarrhea
The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.
FDA approves Xermelo for carcinoid syndrome diarrhea
The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.
FDA approves Xermelo for carcinoid syndrome diarrhea
The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled.
Lipari Foods Issues Voluntary Recall of Various Bulk and Retail Cheese Products Due to Possible Health Risk
Lipari Foods, LLC has issued a voluntary recall of various bulk and retail cheeses manufactured by Deutsch Kase Haus due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Lipari Foods Issues Voluntary Recall of Various Bulk and Retail Cheese Products Due to Possible Health Risk
Lipari Foods, LLC has issued a voluntary recall of various bulk and retail cheeses manufactured by Deutsch Kase Haus due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.