• Regulatory NewsRegulatory News

    FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps

    The US Food and Drug Administration (FDA) has recently released two draft guidances: one with advice for sponsors on the development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), and another offering efficacy and safety considerations for the development of bowel cleansing products for colonoscopy.     Guidance on CRSwNP drugs   The agency provided recommendations for sponsors involved in a CRSwNP drug’s development, including d...
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    FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs

    The US Food and Drug Administration (FDA) has come a long way when it comes to locally acting orally inhaled and nasal drug products (OINDPs) and in the next five years of generic drug user fees, the agency is looking at further progress on some unique challenges, according to a regulatory science report on OINDPs. Background FDA’s Office of Generic Drugs (OGD) explained how the performance of OINDPs has been notoriously difficult to characterize because of a lac...
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    FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray

    As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering new draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can reverse opioid overdoses. The draft guidance is meant to help companies understand what studies need to be conducted to win approval for generics of Adapt Pharma’s Narcan nasal spray, also known as naloxone hydrochloride ...
  • TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants

    Australia's Therapeutic Goods Administration (TGA) has released for comment proposed new warnings on the label of some OTC cough medicines intended for oral use by children. The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow recommendations made by TGA in 2012 to include warnings on products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, phol...