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In the News: October 2021 Regulatory and Development Updates

Camargo

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.”

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FDA Issues First Injunction of its Product Safety Rule

XTalks

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. an Illinois-based processor of sprouts and soy products.

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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The FDA published three binding guidance documents regarding the TRC.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. All packaged foods served or sold on transportation carriers (e.g., By Sophia R. Gaulkin — Last week, the U.S. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

The Pharma Data

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Today, the U.S. 1, 2021, through the present.

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Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Law Blog

Drug manufacturers have had electronic systems in place since 2017. FDA will exercise enforcement discretion concerning the implementation of the electronic interoperable exchange of information between trading partners to the package level. Guidance at 4. So what is FDA going to do? So what is FDA going to do?

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Is 2023 the Year for OTC Naloxone?

FDA Law Blog

Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.