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How GPCR-targeting therapies are advancing the fight against inflammatory disease

Drug Target Review

All these features make GPCRs central to regulating many vital biological processes in the body, including immune responses and inflammation, and thus especially attractive for therapeutic intervention. Meet the author Stephan Schann is Chief Scientific Officer at Domain Therapeutics.

Disease 59
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Companies Shipping Chemicals: “Know the One You’re Dancing With”

FDA Law Blog: Biosimilars

DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. IMC Pro did not store or handle the packages nor maintain records about their contents.

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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

FDA Law Blog: Biosimilars

As it relates to the FDA, FOIA serves as a vital tool for stakeholders including patients, researchers, and regulated industry to better understand the Agencys scientific, policy and regulatory decision-making. FOIA is a U.S. In some cases, previously routine postings are delayed or going unpublished altogether.

FDA 59
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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law Blog: Biosimilars

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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FDA Issues Proposed Order to Facilitate Minor Changes to Solid Oral Dosage Forms to OTC Monograph Drugs, but Such Changes May Come at a Price

FDA Law Blog: Biosimilars

The requirement for the single-unit or unit-dose containers is not a substitute for special packaging, i.e., child resistant packaging required for certain products under the Poison Prevention Packaging Act and implementing regulations. See 16 C.F.R.

FDA 59
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ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

FDA Law Blog: Biosimilars

s John W.M. s John W.M.

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Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.