Alta Sciences

MARCH 4, 2025

The CCALC is a grassroots organization that was founded by several pharmaceutical industry members seeking clarity around the conduct of abuse and dependence potential assessments for novel drugs in development. This was in 2006, at a time when the FDA guidances on these topics had not yet been published.

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Clinical Trials FDA Drug Development Trials 52

Drug Target Review

JANUARY 16, 2025

She has a PhD in Microbiology and Cell Biology from the University of Illinois, followed by work in biochemistry as a post-doctoral fellow at UCSF. Nature Reviews Drug Discovery , 7(7):608624, 2008. Pharmaceuticals , 16(7):996, 2023. Ajay N Jain Ajay is VP of Research for the Optibrium s BioPharmics Division. Springer, 2019.

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Drug Development Small Molecule Drugs FDA Approval 52

Drug & Device Law

DECEMBER 11, 2023

Defendant] does not deny that it, the doctor, and the hospital are potential joint tortfeasors. . . . Merrell Dow Pharmaceuticals, Inc., GlaxoSmithKline , 2008 WL 11515533, at *3 n.10 Knoll Pharmaceutical Co. Synthes Corp. , Alfonzo-Larrain , 490 U.S. See also Todd v. 2d 1173, 1176 (7th Cir. 1991); Atoe v. Allergan, Inc.

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Production Pharmaceuticals Hospitals Doctors 102

Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. Senju Pharmaceutical Co. , Wyeth Pharmaceuticals , 471 F. Boehringer Ingelheim Pharmaceuticals, Inc. 28, 2023) (“ CPAP I ”), addresses primarily medical monitoring. Sinclair v.

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Production Trials Treatment Pharmaceuticals 52

Drug & Device Law

OCTOBER 10, 2022

The drug at issue is the only FDA-approved pharmaceutical treatment for ATTR-CM (although off-label use of other drugs, and organ transplant, are sometimes used as treatments). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

Drugs 52

Drugs FDA Approval FDA Disease 52

Drug & Device Law

JUNE 28, 2022

See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. However, one state’s attempt to prohibit doctors in that state from prescribing an FDA-approved opioid did produce interesting precedent (which we previously discussed here and here ). Bayer Healthcare Pharmaceuticals, Inc.

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FDA Approval FDA Drugs Regulations 116

Drug & Device Law

JUNE 6, 2022

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 2008) (applying Texas law and discussed here ), several times. Teva Pharmaceuticals USA, Inc. ,

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. Bayer HealthCare Pharmaceuticals, Inc. , Our 2008 post discussed Ackermann v. Wyeth Pharmaceuticals , 526 F.3d Today we examine it in more detail.

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Testimonials Doctors Production Laboratories 59