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Duane Morris LLP
Patrick C. Gallagher
Patrick C. Gallagher
Duane Morris LLP
FDA Warning Letters Explained: An Opportunity, Not A Threat
24 Nov 2023 | United States
FDA Issues Second Warning Letter Of 2023 Over Potentially Misleading Efficacy Claims Regarding Inhaler
31 Aug 2023 | United States
FDA Issues Draft Guidance On Pre-market Submissions For Patient-Matched Guides To Orthopedic Implants
18 Aug 2023 | United States
FDA Draft Guidance Recommends Info To Include In Patient-Matched Guides To Orthopedic Implants
17 Aug 2023 | United States
FDA Issues New Nitrosamine Impurities Guidance
11 Aug 2023 | United States
Nitrosamine Impurities FDA Guidance
11 Aug 2023 | United States
Latest FDA Guidance Includes Minor Procedural Updates To Q-Subs For Medical Devices
12 Jul 2023 | United States
FDA Seeks Input From Life Sciences Industry On Controlling Nitrosamine Impurities
16 Jun 2023 | United States
CMS Issues Initial Guidance On Medicare Drug Price Negotiation Program
11 Apr 2023 | United States
FTC Publishes Proposed Changes To Guides Concerning The Use Of Endorsements And Testimonials In Advertising
29 Jun 2022 | United States
FDA Issues Guidance On Compounding Animal Drugs From Bulk Drug Substances
03 May 2022 | United States
FDA Issues Guidance On Compounding Animal Drugs From Bulk Drug Substances
27 Apr 2022 | United States
FDA Final Guidance On Initiating Voluntary Recalls: Be "Recall Ready"
18 Mar 2022 | United States
District Court Of Delaware Rules For Generic Pharma's Use Of Skinny Label, But Permits Induced Infringement Suit To Proceed Against Insurer
14 Feb 2022 | United States
FDA Issues Final Rule On "Intended Use"
29 Sep 2021 | United States
Federal Circuit's Rehearing Decision Confirms Induced Infringement Even When Skinny Label Was Used
31 Aug 2021 | United States
FDA Issues Final Guidance On Form And Content Of Unique Device Identifier Labeling System
27 Jul 2021 | United States
FDA's Additional Draft Guidance On Biosimilarity And Interchangeability To Seek Comments And Suggestions By January 19, 2021
17 Dec 2020 | United States
Federal Circuit Holds That, For Venue Purposes, Patent Infringement Occurs Only In Districts Where Actions Related To ANDA Submissions Occur
20 Nov 2020 | United States
Federal Circuit Finds Induced Infringement Of Drug Patent, Even When Skinny Label Was Used
04 Nov 2020 | United States
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