Honey Sachets Are Latest Sweet Spot For Selling Products With Undisclosed ED Drugs In US
FDA's warnings to four companies selling honey sachets containing undisclosed ED ingredients are latest examples of businesses marketing noncompliant products because the agency doesn't have sufficient funding to regulate the market, says University of Connecticut pharmacy professor Michael White.
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House Has Slim Boost For FDA FY2023 Spending, But Wants Slimmer Budget Document From Agency
Appropriations Committee publishes FY2023 spending bill and report FDA day before it votes on the legislation. It recommends increasing FDA’s budget by less than $400m from its current appropriation to $6.48bn.
Senate FDA User Fee Bill’s Mandatory Supplement Listing Provision Unites Industry In Opposition
Senate HELP Committee didn’t add amendments to user fee bill to protect confidential information and prevent FDA over-regulation in an MPL program, trade groups say. MPL proponents join opponents in saying language in S.4348 isn’t the answer.
Delay For Sanofi’s OTC Cialis Study In US Could Be Sign of Hurdles Holding Back Other Switches
Potential hurdles FDA put in front of Sanofi’s planned tadalafil switch could be sign for agency’s expectations for moving other Rx ingredients to OTC. Sanofi announced its planned actual use trial to support OTC tadalafil use was “placed on clinical hold due to matters surrounding the protocol design.”