Summary of: Alliance webinar with CDRH Director Dr. Jeffrey Shuren
Dr. Shuren addressed the Alliance for a Stronger FDA this week. An audio copy of the program is here. His remarks are briefly highlighted below.
“Hurry up and wait” most likely scenario for spending bills; options if Congress can’t reach agreement on spending levels.
Appropriations bills are moving, but “hurry up and wait” is the most likely scenario.
Spending bills can move because of deeming resolutions.
Options if Congress can’t reach agreement on spending levels.
How long Dr. Woodcock can stay acting?
CDRH Director Jeff Shuren provides Alliance with valuable insights.
Summary of: Alliance webinar with Judy McMeekin, Association Commissioner for Regulatory Affairs
FDA’s Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin provided the Alliance with a far-reaching and informative webinar regarding the Office of Regulatory Affairs’ (ORA) critical role in assuring safe food and medical products to the American people. ORA, with more than 5,000 staff in 230 offices in 49 states and other posts overseas is the lead office for FDA’s regulatory field activities.
Appropriations bills move in the near term (House); face difficult long-term prospects. Progress on FDA’s New Era of Smarter Food Safety Blueprint.
Appropriations bills move in the near term but face difficult long-term prospects. Plan on attending our upcoming Alliance Webinar with CDRH Director Jeff Shuren (July 22), which follows our informative July 14 Webinar with FDA Associate Commissioner for Regulatory Affairs Judy McMeekin that is summarized in this week’s Analysis and Commentary. Significant progress is reported in FDA’s New Era of Smarter Food Safety Blueprint.
Q&A on the President’s FY 21 budget request and the priorities of key House appropriators
Is the proposed increase in the House bill $247 million or $257 million?
House Appropriations Committee approves FY 22 Ag/FDA Appropriations bill; the Alliance reacts positively to the House bill.
House Appropriations Committee approves FY 22 Ag/FDA Appropriations bill, with full House consideration expected in July. The Alliance reacts positively to the House bill. Upcoming Webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14) and CDRH Director Jeff Shuren (July 22). FDA is working on extra ways to hire additional personnel.
Under the House subcommittee bill, BA Salary and Expenses is proposed to increase about $247 million and BA Buildings and Facilities is proposed to increase about $10 million.
Under the House subcommittee bill, BA Salary and Expenses is proposed to increase about $247 million and BA Buildings and Facilities is proposed to increase about $10 million. The two combined equal the Subcommittee’s announced $257 million increase for FY 22 above FY 21 funding levels.
House mark-up continues good prospects for FDA in FY 22. The Alliance reacts positively to the House Subcommittee mark for FDA.
House mark-up continues good prospects for FDA in FY 22. The Alliance reacts positively to the House Subcommittee mark for FDA. Upcoming Webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin, July 14; CDRH Director Jeff Shuren, July 22.
I often start Hill meetings by asking staffers when they were last in a meeting where consumers and industry came in the door together and delivered a joint message in support of a federal agency.
I often start Hill meetings by asking staffers when they were last in a meeting where consumers and industry came in the door together and delivered a joint message in support of a federal agency. It is a powerful message for everyone we meet with that FDA is special and worthy of their support. It is also a unique experience for many of them to see consumers and industry together.
Appropriations bills are delayed but set to begin moving. Getting a budget resolution (or, at a minimum, a measure to "deem" a discretionary allocation to the appropriations committees) is key.
Appropriations bills are delayed but set to begin moving. Getting a budget resolution (or, at a minimum, a measure to "deem" a discretionary allocation to the appropriations committees) is key. Final appropriations action is uncertain. Upcoming Alliance webinars - Associate Commissioner for Regulatory Affairs (ACRA) Judy McMeekin (July 14) and CDRH Director Jeff Shuren (July 22).