Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. While current and future innovations in drug development hold immense promise, there are potential dangers that have not yet been accounted for in regulatory standards. References Allen, L.

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Codon

FEBRUARY 27, 2024

In 2010, seven members of a soccer team in Oregon were infected with norovirus after touching a reusable grocery bag, which was covered in viral particles, and then eating the food inside. A startup that makes such a spray has gained an EPA license to sell its product to customers in the consumer, commercial, and healthcare sectors.

Virus 73

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. But in 2010, this guy participating in a challenge trial in Oxford committed sexual assault and then ran from the law and was a fugitive, while participating in this study.

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014.

FDA 40

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The Pharma Data

OCTOBER 14, 2020

It was granted orphan drug designation for the treatment of narcolepsy in 2010. Food and Drug Administration in August 2019 for the treatment of excessive daytime sleepiness in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019. WAKIX is a selective histamine 3 (H?)

FDA Approval 40

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The Pharma Data

MAY 13, 2021

The Executive Director of the Institute for Behavior Change (IBC), licensed psychologist and certified school psychologist Steve Kossor, has been involved in the planning and delivery of what became known as Intensive Behavioral Health Services (IBHS) in Pennsylvania since 1981. push(arguments)},i[r].l=1*new Want to work with us? Click here.

Treatment 52

Treatment Production Licensing Licensing 52

The Pharma Data

AUGUST 3, 2021

The Company has initiated discussions with regulators on the Phase 3 study design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer.

Biosimilars 52

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego).

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego).

Therapies 52

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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. Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & Gene Expression and Regulation. Science (2010).

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DNA Cell Biology Molecular Biology Engineering 98

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Regulations FDA Science Production 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. Nature Reviews Genetics (2010). Link The second decade of synthetic biology: 2010–2020 , by Meng F. & & Collins J.J.

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Dental Organization for Conscious Sedation, LLC , 2010 WL 5146603, at *2-3 (E.D. 13, 2010) (whether “education, information, and protocols” were products could not be decided on the pleadings). In United States v.

Production 52

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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. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices.

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2010 WL 894054 (N.D.

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Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Smith, LLC , 2010 WL 11566367, at *7 (N.D.

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