FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
clinicaltrialsarena on MSN11d
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
GlobalData on MSN7d
MHRA seeks input on new regulatory guidance for cancer vaccines
The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.
JD Supra28d
FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research
Indeed, in new draft guidance on the use of AI to support regulatory decision-making for drug and biological products, FDA described using ... part of the diagnostic process and is therefore ...
Rolling Out12d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
Aptar's Profitability Improving Due to Pharma Growth and Cost Controls
Aptar has a narrow economic moat, with durable switching costs in the Pharma business supported by intangible assets throughout the product portfolio from expertise in product regulation, design, and ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
JD Supra6d
End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...
Morningstar6d
Pluristyx Announces Filing of Drug Master File for PluriBank™ iPSC Lines with U.S. FDA
Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug ... FDA regulatory submissions to streamline the process.
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...
Roll Call25d
FDA authorizes first nicotine pouches
The Food and Drug Administration ... the same regulatory process as a tobacco product. Zyn is a subsidiary of Philip Morris International. “To receive marketing authorizations, the FDA must ...