• Regulatory NewsRegulatory News

    European Commission: Cranberry Products Are Not Medical Devices

    The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive." The final decision, following a draft decision in ...
  • Regulatory NewsRegulatory News

    Updated: European Commission: Cranberry-Derived Products are not Medical Devices

    Updated with comment from Medical Brands' CEO. The European Commission has released a draft decision that would mean the group of products depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) extract, in order to prevent or treat cystitis, also known as bladder inflammation or infection, should not be classified as medical devices. The need for the European Commission to make this decision on cranberry-derived products came as some companies  -...
  • Regulatory NewsRegulatory News

    28 Days Later: FDA's Clinical Endpoint to Stop the Horror of Complicated Abdominal Infections

    New guidance issued by the US Food and Drug Administration (FDA) is intended to make it easier for pharmaceutical companies to develop drugs to treat "complicated" intra-abdominal infections (cIAIs), with a goal of achieving a successful outcome within 28 days of a patient starting treatment. Thinking About Development Questions The final guidance document, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment , is an update to a 2012 draft g...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...
  • Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress

    A steady drumbeat of recalls related to potentially non-sterile products manufactured at compounding pharmacies continues, with the US Food and Drug Administration (FDA) issuing announcements this weekend that Specialty Compounding LLC was recalling "all lots of sterile medications within expiry" after at least 15 patients experienced bacterial infections after being given the medication. Background FDA regulates pharmaceutical compounders differently than traditional m...
  • FDA Guidance Establishes Specific Recommendations for Ear Infection Therapies

    A new guidance document released by the US Food and Drug Administration (FDA) is intended to assist sponsors developing therapies to treat bacterial ear infections. The guidance, Acute Bacterial Otitis Media (ABOM): Developing Drugs for Treatment , finalizes the draft version of the same guidance, which was released in January 2008, and revised a 1998 guidance by a similar name. "This guidance focuses on specific drug development and trial design issues that are un...
  • FDA Releases Draft Guidance on Abdominal Infection Products

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to the development of new pharmaceutical therapies for the treatment of complicated intra-abdominal infections (cIAIs), clinically common infections encompassing a wide swath of types of bacteria and locations. These infections are frequently diagnosed as intra-abdominal abscesses, perforations of the stomach or intestine, peritonitis, appendicitis with perforations or peria...