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  • Regulatory NewsRegulatory News

    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
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    FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote

    The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications. While Hopsira's epoetin alfa biosimilar has been approved in Europe since 2007, FDA rejected the company's first attempt at US approval in October 2015, just after Pfizer completed its acquisition of Hospira. At...
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    FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate. The warning letter and deficiencies cited by FDA have major ramifications beyond Pfizer too. The letter has delayed the marketing of Momenta’s generic version of Teva’s blockbuster multiple sclerosis ...
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    European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (9 February 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ENVI Calls for EMA to Maintain Budgetary Reserve to Mitigate Brexit Volatility A public health committee has called for officials to clear the European Medicines Agency (EMA) to maintain a budgetary reserve for use in the event of Brexit-related volatility. The committee thinks such a reserve is needed if EMA is to cope with the unforeseen costs and unfavorable exchange...
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    Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents

    Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit. The opinion hinges on an important concept linked to the patenting of pharmaceuticals, the use of CMOs and the manufacturing processes necessary to produce pharma...
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    NIST Kicks Off Wireless Infusion Pump Cybersecurity Project

    The National Institute of Standards and Technology (NIST) is launching a project to improve the cybersecurity of wireless infusion pumps. To do so, NIST's National Cybersecurity Center of Excellence (NCCoE) is looking for vendors to provide it with the components and technical expertise required to simulate the hospital environment in which infusion pumps operate. In a notice published in the Federal Register Monday, NIST said the goal of the project is to help health...
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    Updated: Pfizer Receives FDA Untitled Letter Over YouTube Video

    The US Food and Drug Administration’s Office of Prescription Drug Promotion has hit Pfizer subsidiary Hospira with an untitled letter over the company's "misleading" YouTube video on its sedative Precedex. FDA says the video, titled, “What to Expect: Hospira Precedex (dexmedetomidine HCl Injection) by Hospira, Inc. (Hospira) for Precedex (dexmedetomidine hydrochloride) injection,” was never submitted to OPDP and is misleading “because it omits risks and material facts as...
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    FDA Form 483s From India: A Deep Dive Into the Problems

    Untitled Document A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency. And although the products described in the 483s have been redacted, and a majority of the FDA observations are for relatively commonplace documentatio...
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    Security Researcher Says Additional Hospira Infusion Pumps Vulnerable to Hacking

    A prominent security researcher is warning that additional infusion pump models manufactured by Hospira are vulnerable to intrusion by hackers, just weeks after a similar warning prompted action by the US Food and Drug Administration (FDA) and the US Department of Homeland Security (DHS). Background In May 2015, DHS' Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) released a warning regarding potential security vulnerabilities within Hospira's LifeCa...
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    FDA Issues Stern Warning Letter to Hospira Over Manufacturing Lapses in Italy

    The US Food and Drug Administration (FDA) has just issued biopharmaceutical manufacturer Hospira a new Warning Letter—the company's seventh in the last seven years —regarding alleged deficiencies found at the company's Liscate, Italy manufacturing facility. Background The letter, issued 31 March 2015, references a May 2014 inspection of Hospira's Liscate facility where the company manufactures finished pharmaceutical products. During the seven-day inspection, FDA said...
  • Problems at Hospira's Rocky Mount Facility Continue as FDA Issues Second Warning Letter

    Life sciences manufacturer Hospira is once again the subject of a Warning Letter from the US Food and Drug Administration (FDA) alleging deficiencies at a long-troubled North Carolina manufacturing facility. Background Hospira has been the subject of five prior warning letters since August 2009, all of which related to current good manufacturing practice (CGMP) deficiencies at various plants and locations. Company Date of WL Location Subject of Warning Letter ...
  • FDA's Battles Over Generic Drug Labeling Continue on a Smaller Scale

    There has been no shortage of tension between the US Food and Drug Administration (FDA) and generic drug manufacturers as of late. And if a recent spat between FDA and Hospira is any indication, don't expect that tension to ease any time too soon. Background As Regulatory Focus has explored at length , FDA is currently in something of a one-sided fight against the branded pharmaceutical industry, the generic pharmaceutical industry and legislators. FDA has hoped to u...