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Regulation/Legislation (Health)

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Regulation

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Latest From Health & Regulation

House Energy And Commerce Lists Infant Formula Crisis First In Stating FDA Oversight Priorities

Infant formula supply shortage affecting US since early 2022 is first among multiple FDA concerns Energy and Commerce GOP leadership stated in plan submitted to Oversight and Rules Committee, as required in a standing House rule.

FDA Coronavirus COVID-19

US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

Manufacturing Regulation

Sanofi And PAGB Call On UK MHRA To Explore Exclusivity For First-In-Class Rx-To-OTC Switches

Exclusivity for first-in-class Rx-to-OTC switches should be on the table as part of a wider review of the UK’s reclassification process, say Sanofi and PAGB.

United Kingdom Health
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

House Energy And Commerce Lists Infant Formula Crisis First In Stating FDA Oversight Priorities

Infant formula supply shortage affecting US since early 2022 is first among multiple FDA concerns Energy and Commerce GOP leadership stated in plan submitted to Oversight and Rules Committee, as required in a standing House rule.

FDA Coronavirus COVID-19

US FDA Catches Up On Monograph Petitions: Denies Antiseptic TFM Requests Made In 2001

Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.

FDA OTC Drugs

France Expanded Free Access Scheme In 2022 With OTC, Herbal And Homeopathic Additions

Record of OTC drugs, traditional herbal medicines and homeopathic medicines added to France's "free access" pharmacy self-selection scheme in 2022.

France Health
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