Regulatory
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According to Marinomed, the company’s Coldamaris anti-virus nasal spray has been approved in Canada as a “natural health product.” The over-the-counter product has been registered in Europe, where it is licensed to Boehringer Ingelheim, since… Read more . . .
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According to GSK and Theravance, the FDA has accepted their NDA for the Anoro Ellipta umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD, with a PDUFA date of December 18, 2013.… Read more . . .
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The American Association for Laboratory Accreditation (A2LA) has accredited Next Breath, LLC, to ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) 17025:2005a, the primary standard for testing and calibration labs. Next… Read more . . .
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According to Pharmaxis, the company has obtained up to $40 million from NovaQuest Pharma Opportunities Fund III for development, manufacturing, and commercialization of Bronchitol mannitol inhalation powder in the US and EU. At the same… Read more . . .
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The FDA and the US Federal Trade Commission (FTC) have issued a warning to a Florida company called Flu and Cold Defense LLC regarding its claims for an over-the-counter nasal vapor inhalation product called GermBullet.… Read more . . .
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The Swedish Medical Products Agency (MPA) has granted Bend Research a certificate of compliance with European Union good manufacturing practice (GMP) regulations for the company’s manufacture and testing of clinical pharmaceutical supplies. All European health… Read more . . .
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At its January 29, 2013 meeting, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the 5 µg dose of Boehringer Ingelheim’s Striverdi Respima olodaterol soft mist inhaler for the maintenance treatment of COPD.… Read more . . .
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The UK’s National Institute for Health and Clinical Excellence (NICE) has issued a qualified recommendation for Forest Lab’s Colobreath colistimethate sodium and Novartis’s TOBI Podhaler tobramycin dry powders for inhalation as options for the treatment… Read more . . .
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On January 22, 2013, the FDA published its final cGMP rule for combination products in the Federal Register. According to the rule’s summary, “This rule is intended to promote the public health by clarifying which… Read more . . .
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According to Meda, the EU has approved the company’s Dymista azelastine/fluticasone nasal spray for the treatment of seasonal and perennial allergic rhinitis. Meda submitted an MAA for the product in late 2011. The company announced… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA