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. What happens when a drug is not stored in its original container or within a licensed facility? The major takeaway: 88% (2560 lots) were extended beyond the original expiration date.

Science 40

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.

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” no[r] a marketing product” under Lanham Act). City of Madera , 2005 WL 1683736, at *13 (E.D. July 11, 2005), aff’d , 277 F. Leading Market Technologies, Inc. , Paragon 28, Inc.

Production 52

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. . . . 2005) (no causation where prescriber “testified that he selected. . . Accord Wyeth Laboratories, Inc.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by] 247d-6d(b)(8). Strike two. The suit “relates to” – at least – “the. . . Strike three.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59