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  • Regulatory NewsRegulatory News

    FDA Warns Four Foreign Drug Manufacturers

    The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland. The warning letters are part of a wider crackdown by FDA on foreign drug manufacturers, particularly in China and India . Data manipulation has been a primary concern for FDA, in addition to trying to deal with manufacturers that refuse inspections . China For the warning letter sent 26 Se...
  • Regulatory NewsRegulatory News

    FDA: New Postmarketing Study, Black Box Warning for Essure

    This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement. After months of deliberation, the US Food and Drug Administration (FDA) announced on Monday that it will require a new postmarketing study and a black box warning label for Bayer's permanent birth control device Essure. Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pai...
  • Regulatory NewsRegulatory News

    Bayer Refutes Congressman's Claims on Essure Safety

    Editor's Note: On Wednesday, Focus reported allegations raised by Rep. Mike Fitzpatrick (R-PA) during a press call that Bayer's permanent birth control device Essure is associated with far more reports of fetal death than previously reported by the US Food and Drug Administration (FDA). After publication we received a statement from Bayer Healthcare refuting those allegations. In this article we discuss Bayer's response and clarify certain aspects of the claims made...
  • Regulatory NewsRegulatory News

    Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

    Editor's note: After publishing this article, Focus received comments from Bayer refuting the allegations made by Rep. Fitzpatrick. See our coverage of Bayer's comments in a follow up article published Thursday. Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the U...
  • 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...