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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

The FDA Law Blog

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.

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Pharmacy Law and Licensing Highlights 2025

The FDA Law Blog

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. Hyman, Phelps & McNamara, P.Cs

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

The FDA Law Blog

DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 IMC Pro did not store or handle the packages nor maintain records about their contents. of 1-BOC-Piperidone and 138.66 of (2-Bromethyl) benzene. Both chemicals are used in the illicit manufacturer of fentanyl.

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

The FDA Law Blog

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. However, not all information contained in FDA records is disclosable.

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Rising Demand for Pharmaceutical Secondary Packaging Providers

Roots Analysis

On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. . trillion in 2023.

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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

The FDA Law Blog

To be clear, the minor changes are permitted only for OTC monograph drug products that are included in deemed final orders, and not for OTC monograph products that may remain on the market pending FDA monograph orders allowing or prohibiting such products.) The suitable reference product must be a capsule or tablet that is swallowed.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

The FDA Law Blog

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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