The Pharma Data

OCTOBER 19, 2020

20, 2020 /PRNewswire/ — CNS PHARMACEUTICALS AG , Inc. manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Treatment 52

Drug Channels

OCTOBER 19, 2020

Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

Specialty Pharmacies 52

Specialty Pharmacies Science Pharmacy Licensing 52

Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

JUNE 16, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This action will address Louisiana Environmental Action Network v.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). Medicis Pharmaceutical Corp. , 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F. Paragon 28, Inc. 40 (2d Cir.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. Plan B, which utilizes the progestin levonorgestrel that is also used in a number of oral contraceptives, received FDA approval for over-the-counter use in 2006. the state action would be preempted.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

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. . . . Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 692, 694 (5th Cir.

Testimonials 59

Testimonials Doctors Production Laboratories 59

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.” 2006), app. 2006), app. For physicians to prescribe such a safer drug, it must reach the market. 2d at 401.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

FEBRUARY 2, 2023

1974) (applying Texas law), the Fifth Circuit had held: [T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. Novartis Pharmaceuticals Corp. , 2d 1264 (5th Cir.

Production 59

Production FDA Approval Vaccine FDA 59