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  • Regulatory NewsRegulatory News

    FDA to Announce Next Steps in Essure Review

    The US Food and Drug Administration (FDA) says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety. In an update posted to FDA's website Tuesday, the agency says it is reviewing information, including testimony made at a recent advisory panel meeting, medical literature and recent adverse event reports to "identify appropriate next steps." The agency is also cons...
  • Regulatory NewsRegulatory News

    New Bill Directs FDA to Pull Bayer Birth Control Device

    In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure. The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the produc...
  • RAPS' LatestRAPS' Latest

    Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators

    An emerging class of biological products intended to act as the generic equivalents of earlier, branded products is being threatened globally by an obvious, yet complex set of issues, say two experts consulted by Regulatory Focus . The products-known as biosimilars, follow-on biologics or subsequent entry biologics-are intended to act as interchangeable substitutes for other biological products whose patents have expired and are thus eligible for market competition. Whi...
  • As Regulatory Problems Accumulate In India, Clinical Trials Sector Looks to Flee

    Can regulatory oversight simultaneously be both too much and not enough? Such is the case of India, reports The Economic Times , whose regulated industry is protesting both its increasingly strict clinical trial regulations and the dearth of regulatory oversight practiced by the Central Drugs Standard Control Organization (CDSCO). The combination of factors is causing some manufacturers to reexamine their operations in the country, and whether it makes sense to move...
  • EMA Looks Back on a Tough Year as it Forges Ahead

    Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems. The last year saw EMA's long-time Executive Director, Thomas Lönngren, resign in the midst of controversy and a new ED, Guido Rasi, inherit an agency in the midst...
  • Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, CGMP, Design Deficiencies

    The US Food and Drug Administration (FDA) released five warning letters previously issued to companies in the healthcare product sector, including three medical device companies, one pharmaceutical distributor and one supplement manufacturer. William Demant Holdings A/S (Medical Device) FDA's warning letter to William Demant , a Danish medical device manufacturer, cited deficiencies at its Oxford, UK facility found during two December 2011 inspections. The company, w...
  • J&J Earnings Drag as Regulatory Problems Accumulate

    Life sciences giant Johnson & Johnson (J&J) managed to increase first quarter profits by 12.5% despite a decrease in revenue of 0.2%, the company said in a statement. But the company's profits were sorely depressed by a series of regulatory issues, including recalls, shortages and legal battles, reports The Associated Press. Among J&J's many issues during Q1: The US Department of Justice rejected a settlement between the company and the US government ove...