FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The illicit marijuana market remains strong despite state laws legalizing marijuana. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy.

Regulations 59

Regulations Production Drugs FDA Approval 59

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

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.

Vaccine 59

Vaccine FDA FDA Approval Production 59

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. ,

Testimonials 59

Testimonials Doctors Production Laboratories 59

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.

Production 52

Production Trials International Government 52

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. T]hese marketing techniques influence use of the products based on elements other than the scientific content of the communication (as used herein, “persuasive marketing techniques”). Plaintiffs Legal Committee , 531 U.S.

FDA 64

FDA Nurses Production Regulations 64

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Plaintiff received the biologic just months after it had been licensed by the FDA. 341 (2001). In the course of denying the motion, the court misconstrued the law at least once and possibly twice. See 42 U.S.C. § See 21 C.F.R.

FDA 59

FDA FDA Approval Licensing Licensing 59

LifeSciVC

OCTOBER 28, 2024

Today’s market likes products. Investors, especially in the public markets, only want late stage de-risked assets. Or so the conventional wisdom goes in the equity capital markets these days. The tone of today’s market reveals it’s close to suffering those latter conditions. Platforms aren’t in vogue anymore.

Marketing 103

Marketing Licensing Licensing Targeted Protein Degradation 103