Agency IQ

AUGUST 4, 2023

Articles 3(1) and 3(2) of the current European pharmaceutical regulation (EC) No 726/2004 set out requirements for medicinal products that must use the centralized procedure, rather than national approval pathways. These are marketing authorization applications submitted to the EMA and authorized by the EC under Regulation (EU) No 726/2004.

Packaging 40

Packaging Licensing Licensing Regulations 40

Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries.

Therapies 118

Therapies DNA Virus Clinical Trials 118

Codon

MARCH 28, 2023

” By 2004, DARPA entered what might be reasonably called the “Ling/Kruse Era” Around this time, a program manager named Dr. Geoff Ling started what we think is the most highly-funded DARPA neurotechnology project to date: Human Assisted Neuro Devices, or HAND, with at least $150M in funding.

Engineering 52

Engineering Research Science FDA Approval 52

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Trials Production Therapies 40

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.

Regulations 40

Regulations Government Production International 40

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Codon

JANUARY 2, 2024

In 2004, Gilson filed a lawsuit against Rainin, accusing Rainin executives of “a campaign to disparage Gilson's Pipetman products and route customers to their own competing product lines.” The German company that first licensed Schnitger’s 1957 invention, Eppendorf, also made the first disposable polypropylene tips.

Laboratories 111

Laboratories DNA Licensing Licensing 111

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS).

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

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. 2020) (LEAN).

Regulations 40

Regulations Compliance Production Science 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2004). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Current Genetics (2017). Science (2021).

DNA 91

DNA Cell Biology Molecular Biology Engineering 91

Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. Some of the affected former NDAs were approved using drug master files (DMFs).

FDA 40

FDA Science Biosimilars Regulations 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2004). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Science (2021).

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. However, licensed software can be a UCC sale of “goods.”

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. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

FEBRUARY 2, 2023

2004); and Hackett v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir.

Production 59

Production FDA Approval Vaccine FDA 59