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  • Regulatory NewsRegulatory News

    FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

    The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.   Hangzhou Guoguang   The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.   According to the warning letter, Hangzhou Guog...
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    Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine

    Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds. "MSF objects to the granting of an exclusive patent license on a U.S. government-funded invention to a single pharmaceutical company as well as to the lack of conditions to ensure the vaccine will be appropriately developed and made available and ...
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    FDA Offers 2016 Report on Medical Countermeasure Activities

    As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities. With a budget of a little more than $110 million, FDA’s MCM efforts play a  critical role  in protecting the US from dangerous threats and emerging infectious disease threats, such as pand...
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    Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine

    Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi fired back on Tuesday explaining the risks of developing such a vaccine. According to a Federal Register notice from 9 December, the Department of the Army of the US Department of Defense intends to grant an exclusive, royalty-bearing, revocable license on a patent entitled, ‘‘Zika Virus Vaccine an...
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    FDA Form 483: Theranos Initiated Trials Without IRB Approval

    The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB). The one-page FDA report says that the three-day inspection of Theranos' Palo Alto, CA facility in mid-August uncovered evidence that Theranos initiated clinical investigations for two clinical ...
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    Senate Advances $1.1B in Emergency Zika Funds as House Fight Looms

    The Senate on Tuesday voted in favor of providing $1.1 billion in new funds to fight the Zika virus, which continues to spread in Central and South America and is expected to hit the US soon. The 68-29 vote in the Senate means the new funding could be added to an unrelated spending bill, though the funds are significantly less than the $1.9 billion President Barack Obama and the National Institutes of Health (NIH) requested three months ago to fight Zika. The Senate vot...
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    Democrats Renew Call for $1.9 Billion to Fight Zika

    House and Senate Democrats are calling on their Republican counterparts to support a new standalone bill, supported by President Barack Obama, calling for $1.9 billion to fund efforts to combat the Zika virus. The call was made during a press conference on Wednesday, where Senate Minority Leader Harry Reid (D-NV) urged Republicans to act before a week-long recess beginning 30 April, saying, "We need immediate action to fight the Zika virus before it spreads further. We s...
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    Additional Funding to Combat Zika Denied in House Markup of FDA Spending Bill

    The House Appropriations Committee on Tuesday marked up the FY 2017 spending bill for the US Food and Drug Administration (FDA) and decided not to include an amendment adding $1.9 billion in additional funding requested by President Barack Obama to combat the Zika virus. Republicans argued that Obama did not provide enough specifics on where the funds will go and they voted against Rep. Nita Lowey’s (D-NY) amendment that would have attached the Administration’s additiona...
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    FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika

    The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus. In a statement, the agency said it is allowing the test, developed by Roche Diagnostics, to be used to screen blood in areas, such as Puerto Rico , where the virus is actively transmitted. When reached for comment, Roche spokesman Bob Purcell told Focus that screening with the test will begin "in the next few ...
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    Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms

    Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun. And although that love is sure to be a good sign for companies looking to make hefty profits off of the vouchers on the open market (selling for upwards of $350 million), it’s a bad sign for the US Food and Drug Administration (...
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    FDA Sends Three Letters Over Unapproved Zika Diagnostics

    The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics. The letters, sent to MD Biosciences, First Diagnostic Corp. and two Texas hospitals, Texas Children's and Houston Methodist Hospital, call on the recipients to contact the agency within seven days to discuss...
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    Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills

    The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program. The advancement of the bill sponsored by Sen. Bob Casey (D-PA) to extend the pediatric PRV program comes as the US Food and Drug Administration (FDA) told the Government Accountability Office ...