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Perham Gorji

As seen in: JD Supra, American Bar Association, Lexology
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Articles

FDA Proposes Tobacco Registration and Listing Rule Targeting Foreign Manufacturers

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By Perham Gorji, Benjamin Wolf
| JD Supra
Our FDA: Drug & Device Team reviews a rule proposed by the Food and Drug Administration (FDA) that would require foreign tobacco product manufacturers to register their establishments and submit product listings, expanding oversight of imported tobacco products.
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CRLs Made Public: What FDA’s New Policy Means For the Drug Industry | JD Supra

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By Perham Gorji, Jae Min Kim, Christine Lentz
| JD Supra
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to increase transparency. The published records were FDA letters originally issued following reviews of new drug applications (NDAs) and biologics license applications (BLAs) that were subsequently approved between 2020 and 2024.
Open in Who Shared Issue with article?

CRLs made public: What FDA’s new policy means for the drug industry

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By Jae Myung Kim, Christopher M. Mikson, Perham Gorji, Christine Lentz
| Lexology Verified
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to increase transparency. The published records were FDA letters originally issued following reviews of new drug applications (NDAs) and biologics license applications (BLAs) that were subsequently approved between 2020 and 2024.
Open in Who Shared Issue with article?
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