The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...

The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing centers for excellence and an advanced manufacturing technologies designation program.   The omnibus spending bill was signed by President Biden on 27 December and authorizes $3.5 billion in budget authority for the US Food and Drug Administration (FDA) in FY 2023, a 6.5% increase compared to its 2022 bud...

The US Food and Drug Administration’s (FDA) budget request for FY2023 reflects a focus on combatting the nation’s opioid epidemic and improving postmarket surveillance, said Patrizia Cavazzoni, director of FDA’s Center for Drugs Evaluation and Research (CDER). Also, after a low attrition rate during the pandemic, vacancies are now trending upward as CDER staff is departing for new opportunities, she said on call with the Alliance for a Stronger FDA on Monday.   The FDA...

The Senate Appropriations committee has completed its markup of the FY2022 budget for the US Food and Drug Administration (FDA), advancing by a 25-5 vote a bill that would hold the agency to a $200 million increase in its budget authority.   The bill exited the Appropriations subcommittee responsible for FDA funding on Monday with no objections to the Senate’s proposed 6% increase for the agency over FY2021 figures. (RELATED: Senate subcommittee advances FY2022 FDA f...

The US Food and Drug Administration’s FY 2022 budget request to Congress indicates the agency’s wishes to catch up on the backlog of inspections that have been delayed due to COVID-19, improve its drug surveillance efforts to detect possible shortages, and avert shortages for such medical devices as personal protective equipment (PPE).   Many of these requests have been driven by the need to combat device and drug shortages wrought by the pandemic.   The request al...

The US Food and Drug Administration (FDA) is seeking $6.5 billion in funding for FY2022 under President Joe Biden’s $6 trillion budget proposal announced on Friday, an overall increase of $477 million (8%) over the agency’s FY2021 budget.   In a news release, the agency said the $6.5 billion budget would be used for “investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs,” which ...

The House Energy and Commerce Committee will convene Thursday to markup its portions of the budget reconciliation bill that will contain President Joe Biden’s proposed $1.9 trillion COVID-19 relief package.   The budget reconciliation process was created under the Congressional Budget Act of 1974 and enables Congress to fast-track legislation related to taxes, spending and debt limits. Democrats have opted to use the process to allow them to pass the stimulus package...

With Democrats controlling the House, the specifics of President Donald Trump’s Fiscal 2020 budget, released on Monday, may not matter much, but it does feature new attempts to alter US Food and Drug Administration (FDA) processes in order to increase generic drug competition. Similarly to last year’s budget , the 2020 budget looks to save more than $1 billion in Medicare and Medicaid funds by stopping some generic drug applicants, who file first and win tentative appr...

The House and Senate passed a seven-bill spending package on Thursday to fund large portions of the federal government through FY2019. And President Donald Trump has said he will sign the bill.   The spending package comes near the end of a three-week stopgap funding measure to allow the government to reopen after a record 35-day partial government shutdown that began on 22 December 2018 after President Donald Trump refused to sign a short-term spending bill over his...

The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...

Attendees of RAPS’ 2018 Regulatory Convergence in Vancouver, 1–4 October, were among the first to learn about important developments and the latest news on topics including the coming EU Medical Device Regulation (MDR), the US Food and Drug Administration’s (FDA) cybersecurity policies and the results of RAPS’ comprehensive global salary survey of regulatory professionals. The event also marked the first time RAPS’ annual gathering has been held in Canada. The confer...

A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus . The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medic...