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Congress pushes for new FDA authorities to identify …

WEBMar. 23, 2023. A report issued by the Senate Homeland Security and Governmental Affairs Committee Majority highlights the scale and ongoing nature of the drug shortage crisis in …

Actived: 9 days ago

URL: https://www.agencyiq.com/blog/congress-pushes-for-new-fda-authorities-to-identify-and-address-drug-shortages/

EPA updates human health, drinking water assessments for acephate

WEBOn August 30, 2023, the EPA published a second draft revised draft human health risk assessment (DRA) for acephate. The DRA was conducted to evaluate all existing …

Category:  Health Go Health

Major FDA reorganization adds structures to support gene therapy

WEBJan. 04, 2022. In late 2021, the FDA reorganized several of its internal operations to concentrate or delegate certain organizational functions – including bracing for an …

Category:  Health Go Health

A look at what remains on FDA’s 2022 guidance agendas

WEBAs of October 12, 2022 the FDA four centers (CDER, CBER, CDRH and CFSAN) have released 58 guidance documents that were planned for release as part of their guidance …

Category:  Health Go Health

FDA unveils details about major proposed changes to organization

WEBDec. 13, 2023. The FDA today announced that it has concluded work on a draft plan that – if enacted following an extensive feedback process – would result in some of the most …

Category:  Health Go Health

FDA comes full circle with new guidance on testing products

WEBMay. 10, 2023. The FDA has a long and sordid history with the toxic compound diethylene glycol (DEG), having received much of its original regulatory authority after a major …

Category:  Health Go Health

Diagnostics landscape analysis: Key issues and a look ahead at 2024

WEB2023 was a significant year in diagnostics policy and regulation, with profound implications for the path forward in 2024. There has been regulatory upheaval on both sides of the …

Category:  Health Go Health

MHRA, FDA and Health Canada offer “guiding principles” for

WEBOct. 24, 2023. Regulators from the U.S., the U.K., and Canada previously released guiding principles for good machine learning practices. Now, the trio have just published a new …

Category:  Health Go Health

Key takeaways from FDA’s contracted report on legacy medical …

WEBNov. 20, 2023. A new FDA-commissioned report provides recommendations on the next steps in managing cybersecurity risks for medical devices. The FDA, industry and …

Category:  Medical Go Health

Diagnostic Update: Pre-sub acceptance, predicting the transition

WEBJun. 01, 2022. Leadership from CDRH’s Office of In Vitro Diagnostics (OHT7, previously known as OIR) provided a regular bi-weekly update to diagnostic and test developers on …

Category:  Health Go Health

FDA guidance clarifies requirements for reporting drug

WEBApr. 05, 2023. Today, FDA published a new draft version of a COVID-19-era final guidance that details when and how sponsors should notify FDA of supply chain disruptions or …

Category:  Health Go Health

EPA proposes national primary drinking water regulation for

WEBThe EPA has proposed a National Primary Drinking Water Regulation (NPDWR) establishing new enforceable maximum contaminant limits (MCLs) for certain per- and …

Category:  Health Go Health

Legislative Update: As end of year omnibus approaches, a

WEBNov. 29, 2022. The 117th Congress is running against and end-of-year deadline to pass legislation, including a full government funding measure, before the start of the 118th …

Category:  Health Go Health

EMA’s 2023 new medicines report suggests return to pre …

WEBThe 2023 report is out, and the numbers suggest a possible return to pre-pandemic volumes. In 2023, the EMA issued a positive opinion for 77 products, of which 39 …

Category:  Health Go Health

FDA proposes first update to orthopedic device coating guidance …

WEBFDA proposes first update to orthopedic device coating guidance since 1990s. The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance …

Category:  Health Go Health

Congress prepares to markup pandemic legislation, all but …

WEBQuick background: the Pandemic and All-Hazards Preparedness Act. The Pandemic and All-Hazards Preparedness Act was originally passed in 2006. That law built upon …

Category:  Health Go Health

New EPA PFAS framework expects most PFAS to be PBTs

WEBPFAS, PBTs, and EPA regulation. Per- and polyfluoroalkyl substances (PFAS) are a wide class of synthetic organic chemicals that are used across industrial and commercial …

Category:  Health Go Health

EPA publishes draft Meaningful Involvement Policy

WEBNov. 16, 2023. The Environmental Protection Agency has released a draft of its Meaningful Involvement Policy, an update of a 2003 policy, which seeks to improve the interactions …

Category:  Health Go Health

Kyriakides proposes 'immediate, risk-based' MDR extension at

WEBDec. 09, 2022. Commissioner Stella Kyriakides proposed an immediate and risk-based extension to the Medical Device Regulation (MDR) transition period today at the E.U. …

Category:  Medical Go Health

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