Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

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Packaging Licensing Licensing Regulations 40

Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S. Enter the beyond-use date.

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Science FDA Packaging Production 40

Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

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Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). Leading Market Technologies, Inc. , 2016) (applying Georgia law), held that digital marketing software was “a service and not a product.” Gray Loon Outdoor Marketing.

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Production International Trials Government 52

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2001), aff’d , 358 F.3d Stryker Co. , 3d 568, 576-77 (6th Cir. Parke, Davis & Co. ,

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Testimonials Doctors Production Laboratories 59

Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. 247d-6d(b)(8). Strike two. The suit “relates to” – at least – “the. . . development, clinical testing or investigation, . . Strike three.

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Vaccine FDA FDA Approval Pharmacy 59