• FDA Links up With EU Law Enforcement Agency Europol to Combat Fake Pharmaceuticals

    The US Food and Drug Administration (FDA) is stepping up its attempts to go after online pharmacies peddling counterfeit and fake medicines to US consumers, announcing that it is embedding one of its agents with EU's law enforcement agency, Europol. Background: Counterfeiting US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop pr...
  • FDA Wants Supply Chain Security Pilot Program to Continue

    Call it ironic timing. On the same day Congress announced the removal of a pharmaceutical supply chain protection system from the pending Food and Drug Administration Amendments Act (FDAAA) , the US Food and Drug Administration (FDA) announced it is looking to continue a supply chain protection pilot program. The initiative, called the Secure Supply Chain Pilot Program, was launched in January 2009 with the intent of better securing finished pharmaceutical products ...
  • EMA Switches to Electronic Submission for Plasma Product Applications

    The European Medicines Agency (EMA) announced this week the launch of a new electronic form for submitting plasma master file (PMF) application to the agency, replacing two existing forms. Plasma products are protein-based medicinal products typically utilized in blood transfusions, and are regulated by EMA . Sponsors looking to obtain certification for the plasma-based product must submit the PMF, which looks to control plasma source material, data and facilities inspe...
  • Consumers Warned of Fake Adderall in US

    The US Food and Drug Administration (FDA) warned consumers on 29 May of counterfeit copies of Teva Pharmaceutical Industries' attention deficit hyperactive disorder (ADHD) drug Adderall, saying some consumers had obtained copies of the drug containing the incorrect active pharmaceutical ingredients (APIs) through an online pharmacy. ADHD drugs like Adderall use a combination of APIs known as amphetamine salts. In the case of Adderall, the drug contains dextroamphetamine ...
  • Australian Adverse Event Database Hits Milestone

    Australia's Therapeutic Goods Administration (TGA) announced its adverse reactions database hit a milestone 4 April, logging a quarter of a million valid reports. The database, which has been running since 1971, is used by TGA to determine is regulatory action is necessary to protect the public from an already-approved product. "The TGA would like to thank all report contributors," the agency said in a statement. "Such information is vital to TGA efforts to promote the ...
  • Australia Launches Simplified Medical Device Adverse Event Reporting System

    Australia's Therapeutic Goods Administration (TGA) released a new online system for reporting adverse events (AEs) attributable to medical devices this week. In a 14 March press release, TGA noted that the system "consists of forms with easy-to-follow instructions for users and sponsors and manufacturers." Once the medical device AE report has been submitted, "any follow-up or final reports will still have to be submitted by email, fax or mail" until TGA is able to lau...