• EMA Initiates Review of Low-T Medications

    The European Medicines Agency's (EMA) has announced it will initiate a review of testosterone-containing medicines following concerns that the drugs, used primarily to treat a condition commonly known as "Low-T," may cause an elevated risk of cardiovascular side effects. Background Those concerns were first raised by the US Food and Drug Administration (FDA) in February 2014 following the publication of two separate studies in the Journal of the American Medical Asso...
  • FDA Data Mining Project Proposal Once Again Withdrawn

    Earlier this week, Focus reported that a data mining project once abandoned by the US Food and Drug Administration (FDA) for lack of funding had been resurrected by the agency. Now, just days after the agency announced the project's return, it is once again cancelling the project-for now. Background FDA's data mining proposal has been in the works for more than a year. In April 2013, the agency established a notice indicating that it wanted to work with an outside com...
  • FDA Resurrects Data Mining Project Once Left for Dead

    The US Food and Drug Administration (FDA) has resurrected a once-canceled project intended to better mine data about adverse drug reactions from literature reports. Background FDA regularly puts out requests for proposals and solicitations on the Federal Business Opportunities (FBO) website, and has regularly expressed a keen interest in methods of monitoring adverse event data. In April 2013, for example, it put out a notice indicating it wants a partner to help it bu...
  • EU Launches Probe into Safety of Transvaginal Mesh

    The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a  scientific committee  which conducts risk assessments for EU officials-has announced it is launching an investigation into the safety of transvaginal mesh products used in urogynecologic surgery. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pel...
  • European Commission Committee Clears PIP Breast Implants of Major Health Concerns

    The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards. Background The PIP scandal erupted in late 2011, when regulators determined that the company had bee...
  • New FDA Guidance Explains Process Behind Safety Labeling Changes for Drugs, Biologics

    The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered after initial FDA approval, including the process of making changes and how regulators will enforce existing requirements. Background It is often said that at the time of a drug's approval, relatively little is actually known about its safety. Despite advances in regulatory...
  • EU Regulators Claim Diabetes Medicines Clear of Safety Fears, but Data Key to Finding

    Diabetes drugs of the GLP-1 and DPP-4 class have recently come under intense scrutiny by regulators on both sides of the Atlantic Ocean, with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) expressing strong concerns that the pancreatic risks associated with the drug might well outweigh their benefits. Now, however, EU regulators have reaffirmed their positive benefit-risk assessment, saying that no new concerns could be identified b...
  • FDA Plans Meeting to Assess How to Enhance Safety Monitoring of Dietary Supplements

    The safety of the pharmaceutical supply chain may be of perennial concern for regulators with the US Food and Drug Administration (FDA), but now dietary supplements are due to get some added scrutiny as well thanks to an upcoming meeting on chemical hazards. Background Unlike pharmaceuticals, dietary supplements are technically regulated more closely to food substances, avoiding the lengthy premarket approval process and the clinical trials required to generate substant...
  • FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin

    The US Food and Drug Administration (FDA) has announced that it will give researchers a quarter of a million dollars to help identify the source of a major safety risk now affecting heparin products. Heparin, a mixture of non-standard-length polysaccharides, acts as an anticoagulant under normal circumstances. However, a notable side effect known as heparin-induced thrombocytopenia (HIT) results in a decrease of platelets in the blood resulting in the release of abnormal...
  • Global Networks Lead to Global Scandal as MHRA Defends Against Questionable Ranbaxy Practices

    For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory partners to ensure that products are safe for consumption. Now UK regulators are learning a related lesson: A scandal that affects products intended for one country may well affect more than just one regulatory authority. Background On 13 May 2013, Ranbaxy Laboratories pled gui...
  • Draft Guidance Calls for Lengthier Premarket Safety Databases for Rheumatoid Arthritis Treatments

    The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the development of pharmaceutical and biological products meant to treat rheumatoid arthritis, a painful and debilitating autoimmune disease that affects a patient's mobility. Background Rheumatoid arthritis has been something of a minefield for FDA and industry in the last decade. In 2004, pharmaceutical giant Merck voluntarily withdrew its blockbuster drug Vioxx, a non-ster...
  • FDA Announces Meeting Intended to Start Standardization Process for REMS

    US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product. Background REMS were first introduced under the 2007 FDA Amendments Act (FDAAA) , and were meant to act as a regula...