Agency IQ

SEPTEMBER 29, 2023

GDPR) and “is without prejudice” to the laws on protection of intellectual property (2001/29/EC, 2004/48/EC and (EU) 2019/790). The proposed law is subsidiary to Union and national laws on the protection of personal data, privacy and confidentiality (e.g., app interfaces) automatically and through bulk download where technically feasible.

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Agency IQ

JANUARY 26, 2024

In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S. What happens when a drug is not stored in its original container or within a licensed facility? How much shelf-life is the average drug product really losing if it is not labeled with a “true” expiration date?

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The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 175:1091-1101 (1992) 2 Karpusas, M et al., International Immunol. (11):1583 11):1583 (2004) 6 Karpusas M, et al. Structure.

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Codon

JANUARY 2, 2024

Although Rainin became rich selling Gilson’s pipettes, he also went on to build his own pipette empire that he later sold to the Mettler-Toledo corporation, in 2001, for more than $290 million in cash and stock. 2 Eppendorf, a German medical supply company, purchased an exclusive license. Micropipette innovators.

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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. Rescheduling would eliminate a tax burden on cannabis companies, allowing licensed companies to expand investments into state programs and focus on public health in collaboration with law enforcement efforts.

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LifeSciVC

OCTOBER 28, 2024

In-licensing molecules from other players, due to a partner’s strategic shifts, budget challenges, or geographic access, can be a great way to jumpstart early stage companies around more advanced assets. In each moment, we’ve seen a reversion to asset incrementalism (e.g.,

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Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

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New Drug Approvals

APRIL 18, 2025

2001 Feb;36(2):87-96. 2000 May;59(5):1169-86. doi: 10.2165/00003495-200059050-00013. Article ] Katayama H, Spinazzi A, Fouillet X, Kirchin MA, Taroni P, Davies A: Iomeprol: current and future profile of a radiocontrast agent. Invest Radiol. doi: 10.1097/00004424-200102000-00004. Article ] Rosati G: Clinical pharmacology of iomeprol.

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Drug & Device Law

JANUARY 4, 2024

341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. What the FDA calls, rather ponderously, “unapproved uses of approved/cleared medical products,” everybody else in the world (including the Supreme Court in Buckman Co. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. However, licensed software can be a UCC sale of “goods.” Huntington Ingalls Inc. , 3d 1170, 1173 (9th Cir. 2016) (citations omitted). Accord Stark v. 371, 377 (6th Cir.

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Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

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Drug & Device Law

OCTOBER 27, 2022

341 (2001), the U.S. From this, the court concluded the defendants could “comply with both federal and Illinois law by obtaining proof of identity and establishing a donor identification system using photographic identification, a valid driver’s license, or any other non-biometric means.” 2d 808, 812 (E.D. 2013); Heisner v.

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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.

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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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