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  • State and Local Officials Launch Criminal Probe of Compounder as FDA Criticized

    The US Food and Drug Administration (FDA) continues to grapple with problems stemming from an outbreak of fungal meningitis caused by tainted steroid injections manufactured by the Massachusetts-based New England Compounding Center (NECC). The saga is now moving steadily into an investigative stage, with state and federal officials announcing the launch of a criminal probe, legislators calling for a government investigation into the compounding sector, and outside groups ...
  • In Wake of Meningitis Outbreak, Senator Calls for New FDA Authority to Regulate

    In the wake of a widespread outbreak of meningitis, at least one US senator is calling for new authority to be given to the US Food and Drug Administration (FDA) to make its authority to oversee compounding pharmacies clearer and more robust. In remarks reported by CBS New York , Sen. Richard Blumenthal (D-CT) said he remained concerned that FDA did not have sufficient authority to investigate compounders. "We need to bolster the authority of the FDA and make sure ...
  • Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies

    The US Food and Drug Administration's (FDA) regulation of compounding pharmacies has come under fire in the wake of a drug safety problem involving steroid injection shots infected with the meningitis virus. The tainted drugs, traced back to a Massachusetts pharmacy, have already been implicated in five deaths and 35 cases across 23 states-a number officials said is likely to rise in light of the scope of the drug's distribution. But almost as much as the crisis itself,...
  • 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...
  • Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall

    Common are the concerns about good manufacturing practices at pharmaceutical manufacturing facilities. The US Food and Drug Administration sends out dozens, if not hundreds, of warning letters each year to pharmaceutical companies found to be violating basic standards of cleanliness, sterility or quality. Less common are concerns registered by FDA towards pharmaceutical compounding companies, which make medications to unique specifications from scratch using raw material...
  • 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 ...
  • Franck's Pharmacy Issues Extensive, 'Urgent' Recall After Facility Contamination

    Pharmaceutical compounder Franck's Pharmacy issued what it called an "urgent" recall of all of its sterile human and veterinary products after an inspection by the US Food and Drug Administration (FDA) found fungal growth and microorganisms in a supposedly sterile room. "In light of the FDA's findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control,...
  • 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...
  • Senators Call out Pharmacy For Potentially Promoting Supplements Over FDA-Approved Products

    US Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) called upon pharmacy retailer Rite Aid for "potentially deceptive marketing practices […] that could mislead consumers seeking medical advice and direct customers to treat health conditions with dietary supplements." The Senators expressed their concerns in light of accounts that the company has "wellness stations" situated near pharmacy counters which sport consultants donning white jackets that are rep...