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  • Regulatory NewsRegulatory News

    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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    Asia Regulatory Roundup: India Calls for Local Trials Ahead of Dengue Vaccine Launch (10 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Committee Rejects Sanofi’s Request for Dengue Vaccine Trial Waiver A top-ranking Indian health committee has rejected Sanofi’s request to bring its dengue vaccine to market without data from locally run Phase III trials. The ruling by the health apex committee follows positive responses from two other panels, which felt the waiving the requirement for a local Phase I...
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    CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines. The launch of the system, which is part of the Vaccine Adverse Event Reporting System (VAERS) run jointly by FDA and the Centers for Disease Control and Prevention, follows guidance released in August 2015 that offers recommendations on the ele...
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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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    Asia Regulatory Roundup: India Considers Phasing Out Gelatin-Based Capsules (12 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Seeks Feedback on Proposal to Phase Out Gelatin-Based Capsules The Drug Controller General of India (DCGI) is seeking feedback on a proposal to replace gelatin with cellulose in drug capsules. If enforced, the transition would represent a major change for the capsule manufacturing industry, the output of which is currently dominated by gelatin-based products. DCGI i...
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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 ...
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    French Biotech’s Manufacturing Operations Suspended by ANSM

    France’s National Agency for Medicines and Health Products Safety (ANSM) has suspended the manufacturing operations at French biotech company Theravectys’ Villejuif, France-based site for one year (beginning last September) following an inspection in November. ANSM said in a report released Monday that its inspection from 17 to 20 November 2015 of the Paris-based Pasteur Institute spinoff raised 45 deficiencies, including five critical and 17 major deficiencies. The comp...
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    Genetically Engineered Mosquitoes to Aid Zika Response? FDA Plans to Release More Info

    The US Food and Drug Administration's (FDA) acting chief scientist told members of the House Energy and Commerce Committee on Wednesday that FDA is investigating all avenues to combat Zika, including a proposal to release genetically engineered mosquitoes in Florida. Scientists expect that the virus, which has swept across Latin America and the Caribbean, will eventually reach US shores, especially in states like Texas and Florida that have experienced outbreaks of dengu...