The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced changes to how it handles payments for license applications for drugs and clinical trials. Beginning on 1 April 2017, MHRA will allow drug sponsors and clinical investigators to "pay on invoice" for license applications, rather than having to pay in advance and show proof of payment as part of the application process. According to MHRA, "The benefits of the new process include removi...

Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act ( PDUFA VI). And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) detailed how the agency's ability to...

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals. All three officials highlighted the past successes of the user fee programs, and overall, it did not seem as though user fee goals letters would be reworked or that further negotiations would be needed before the b...

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA). While the blueprint offers little detail on what such cuts would actually mean for the agency and pharmaceutical, biotech and medical device industries, the plan says it would recalibrate FDA medical product user fees “to over $2 billion in 2018, approximate...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year." On the informatics front, Woodcock said that last summer, the executive committee of the FDA had a retreat and "the number one item there was improving and really implementing Informatics Process Management and so forth across the w...

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, was in the hot seat on Thursday taking questions from the House Energy & Commerce Committee and urging the representatives to pass re-authorizations of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA). While stressing the successes of the first GDUFA, Woodcock told the committee that this next iteration will provide more fundi...

Beginning on 1 April 2017, the fees collected by the European Medicines Agency (EMA) from applicants and market authorization holders will increase by 1.2%, in line with the inflation rate in the EU for 2016. According to EMA, the European Commission is working to adopt a regulation to adjust the fees . EMA says it will publish complete details on the fees in late March, after the regulation is adopted. "Members felt that matters relating to the structure and level of ...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies. While the agency noted some concerns over the increased costs associated with the fees, it said that the "majority of respondents were content with the fee changes proposed." Last April, MHRA released its business plan for 2016-2017, warning of serious financial troubles for ...

Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs. The setting of the deadline, according to a document obtained by Politico, comes as FDA staff and Congressional staff have recently cancelled meetings to work on the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI), the Medical Device User Fee Act (MDUFA IV), the Generic Drug User Fee Act (G...

The US Food and Drug Administration (FDA) on Thursday offered more details on how the second iteration of the Generic Drug User Fee Act (GDUFA), which must be approved by Congress and President Donald Trump by the end of September 2017, will improve upon the first. One of the biggest proposed changes between the two programs is the creation of a new user fee structure, which was also outlined in the performance goals letter released in October. Gisa Perez, FDA generi...

The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration. Speaking at the FDA/CMS Summit in Washington, DC last week, Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization (BIO), said she's concerned that the user fee agreements, which were negotiated under the Obama Administration, will be reviewed by a new Congress and new administration, each of which mi...

The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday. Last week, FDA released its draft recommendations for changes to its user fee program for medical devices which would allow the agency to collect roughly $999.5 million— an increase of $320 million over the previous five-yea...