Eye on FDA

AUGUST 2, 2022

By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year.

Pharmaceutical Companies 88

Pharmaceutical Companies FDA Pharmaceuticals Drugs 88

Common Sense for Drug Policy Blog

OCTOBER 4, 2024

Changes in Criteria for Identifying Cannabis Dependence: From DSM-IV to DSM-V "Based on NSDUH estimates, rates of cannabis abuse and dependence remained relatively stable from 2002 to 2019, with the highest rates of abuse and dependence among young adults (aged 18–25) (Figure 3-27).

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Engineering Science 52

Common Sense for Drug Policy Blog

DECEMBER 28, 2023

The former NHSDA was redesigned in 1999, and other changes were made to the survey in 2002, which may have increased the sensitivity of the NSDUH for identifying people who are binge drinking and alcohol dependent. Differences in the prevalence of alcohol dependence between the current study and the 2002 study in New Mexico (10.7%

Production 52

Production Treatment Drugs 52

Drug Target Review

MARCH 3, 2025

Meet Professor Jens Christian Schwamborn In 2002, Jens obtained a diploma in Biochemistry from the University of Witten/Herdecke in Germany and in 2005 a PhD in Biology from the University of Muenster in Germany. He worked as a postdoctoral researcher at the Institute for Molecular Biotechnology in Vienna, Austria.

Disease 52

Disease Treatment Therapies Cell Biology 52

The Pharma Data

OCTOBER 16, 2020

from Kosin University Gospel Hospital in South Korea, and colleagues used data from 732,199 individuals who had undergone a national health check-up in 2002 to 2003. FRIDAY, Oct. 16, 2020 — Use of aspirin , metformin , and statins is associated with a lower risk for lung cancer mortality, according to a study published online Sept.

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Hospitals Research Drugs 52

The Pharma Data

MARCH 23, 2021

In the interview, Mr. Reinhardt was asked about the company’s $678 million settlement last year with the United States Government, which resolved claims that during the time period from 2002 to 2011, Novartis used certain promotional programs as a way improperly to induce doctors to prescribe Novartis products, in violation of US anti-kickback law.

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Doctors Government Production 52

Broad Institute

OCTOBER 17, 2023

She’d always had an interest in genetics research and moved to Boston in 2002 to work for a genetics-focused startup. Deik received her bachelor's degree in botany from Connecticut College and immediately went to work at International Paper, a paper manufacturing company, where she engineered trees to grow faster.

Research 98

Research Small Molecule Science Disease 98

Common Sense for Drug Policy Blog

DECEMBER 15, 2023

It showed little change in its usage levels through 2002. Ketamine Use by Students in the US "Prevalence of past-12 month use of ketamine (another “club drug”) among 12th grade students has been below 2% for the past decade and in 2022 stood at 1.2%. This “club drug” was added to the survey in 2000. Since then use has declined in all grades.

Drugs 40

Drugs Research 40

Common Sense for Drug Policy Blog

JUNE 4, 2023

One study demonstrated that the homeless use SCRA to escape from the realities of the streets and provide relief from physical and mental health conditions, similar to the motivations for using cannabis, heroin and crack cocaine within the population (Fountain and Howes 2002 ; Link, 2014 ; Peacock et al., Van Calster, P.

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Common Sense for Drug Policy Blog

AUGUST 22, 2023

The risk environments framework provides a theoretical foundation for doing so ( Rhodes, 2002 ), emphasising the importance of enabling contexts and resources in advancing harm reduction ( Duff, 2009 , 2011 ). 2023 ; Piatkowski et al., 2022 , 2023 a).

Drugs 52

Drugs 52

NIH Director's Blog: Drug Development

OCTOBER 11, 2022

2002, 41 (14), 2596–2599. [3] 2002, 67 (9), 3057–3064. [4] Rostovtsev VV, Green LG, Fokin VV, Sharpless KB. 3] Peptidotriazoles on solid phase: [1,2,3]-Triazoles by regiospecific copper(I)-catalyzed 1,3-dipolar cycloadditions of terminal alkynes to azides. Tornøe CW, Sengeløv H, Meldal M.

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Research Small Molecule Science Clinical Research 52

The Pharma Data

JANUARY 21, 2021

In this study, researchers analyzed records for 5,417 adults and children diagnosed with lupus since 2002 at all U.S. The condition can be fatal, and often causes debilitating bouts of fatigue and pain that prevent nearly half of adult patients from working. Previous estimates of lupus were larger but unverified.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

NOVEMBER 10, 2020

The new study included thousands of British children born between 2000 and 2002. They were assessed at ages 3, 5, 7, 11 and 14 using questionnaires about their strengths and difficulties, which had been completed by parents and teachers.

Hospitals 52

Hospitals Science Research Disease 52

FDA Law Blog: Drug Discovery

JUNE 11, 2023

Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. However, given FDA’s prior announced policy, it is somewhat surprising that only 16% of pediatric labeling changes pursuant to BPCA and/or PREA between 2002 and 2019 were conducted under both the BPCA and PREA.

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FDA Drug Development Production Drugs 40

The Pharma Data

NOVEMBER 23, 2020

In addition to his roles at Legend, Zhang has also been the chairman, an executive director and CEO of GenScript, which he cofounded in 2002. Legend said it did not anticipate any charges being brought against the company in relation to the arrest. Zhang had served as the chairman of board of directors of Legend Biotech since 2015.

Government 52

Government Molecular Biology Regulations Laboratories 52

Common Sense for Drug Policy Blog

JUNE 4, 2023

Although this bill in 2002 was never passed, it was reintroduced in US Congress the following year as the Illicit Drug Anti-Proliferation Act which made it illegal to knowingly lease, rent, or use a space for the purpose of distributing or using controlled substances.

Drugs 40

Drugs International 40

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

The requirement for prior notice originates in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). “Prior notice” informs FDA about the products it can expect to be offered for import into the country. food supply and other food-related emergencies.

Regulations 52

Regulations FDA Compliance International 52

The Pharma Data

NOVEMBER 18, 2020

is a Taiwan biopharmaceutical company that was established in 2002. The above poster presentations will be available online at www.obipharma.com on November 23, 2020. About OBI Pharma. OBI Pharma, Inc.,

Vaccine 52

Vaccine Small Molecule Immune Response Hospitals 52

Drug Target Review

FEBRUARY 29, 2024

Dr Van Laar has been researching neuroprotective approaches for Parkinson’s disease since 2002, with her research efforts focused on mechanisms of neurodegenerative diseases and the therapeutic potential of gene therapy.

Therapies 111

Therapies Disease Clinical Trials Science 111

Drug Target Review

MAY 11, 2023

Elsevier Current Trends; 2002 [cited 2023Apr25]. References: David Bertwistle, Abstract Mutations in the BRCA1 and BRCA2 genes confer a high risk of breast cancer development [Internet]. Current Opinion in Genetics & Development. Available from: [link] RAD51 gene family structure and function – annual reviews [Internet].

DNA 52

DNA Treatment Research International 52

Agency IQ

MAY 28, 2024

law as the Medical Devices Regulation 2002 (UK MDR 2002). The access route used will depend upon the device risk classification under the UK MDR 2002, which MHRA goes on to note might differ from the classification in the CRC that issued the device approval. s work towards a new medical device regulatory framework The U.K.

International 40

International Regulations Licensing Licensing 40

Common Sense for Drug Policy Blog

DECEMBER 20, 2023

By giving people who use drugs the opportunity to consume in a calm, hygienic and supervised environment DCRs also aim to reduce harms resulting from the broader ‘risk environment’ that socially marginalised or excluded groups may be exposed to as a consequence of multiple interacting physical, social, economic and policy factors (Rhodes, 2002). "In

Drugs 40

Drugs Disease Marketing 40

Drug Target Review

JUNE 19, 2024

From 2002 until 2004, Mr Culley was Director of Business Development and Marketing for Immusol, Inc. Mr Culley served from 2007 to 2010 as Mast’s Chief Business Officer and Senior Vice President, from 2006 to 2007 as Mast’s Senior Vice President, Business Development, and from 2004 to 2006 as Mast’s Vice President, Business Development.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

New Drug Approvals

APRIL 19, 2025

Landiolol was approved for medical use in Japan in 2002, [10] [11] in Canada in November 2023, [1] and in the United States in November 2024. [12] This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] 9] It is used as landiolol hydrochloride.

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FDA Clinical Trials Treatment Trials 62

PLOS: DNA Science

JUNE 1, 2023

DEB has been a candidate for a gene therapy since 2002. RDEB is inherited from two carrier parents. A dominant form – DDEB – is less severe, blistering the hands, feet, knees, and elbows. This DNA Science post from 2018 traces the history of the efforts.

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FDA Approval Therapies FDA Disease 52

Common Sense for Drug Policy Blog

SEPTEMBER 12, 2020

In April 2002, Kevin debated DEA Administrator Asa Hutchinson at a conference hosted by Rice University's James Baker Institute. He spoke at nationally recognized legal seminars and testified before Congress on drug related issues. 2005 interview with Kevin on the syndicated radio program Cultural Baggage is available.

Doctors 40

Doctors Government Drugs International 40

PLOS: DNA Science

SEPTEMBER 28, 2023

Assembling panels of SNPs and associating them with health conditions began in 2002 with the International HapMap Project , shortly after the first human genomes were sequenced. A few hundred thousand or even a million SNPs is a shortcut, less to analyze than the 3.2 billion base pairs of a genome.

Disease 52

Disease DNA Science Research 52

Perficient: Drug Development

JUNE 14, 2023

In 2002, Perficient acquired the small technology company I was working for in Chicago. How do you impact the company’s culture of collaboration? What does a typical day or project look like? John and his wife, Merri I have been with Perficient for 19 years.

Science 52

Science Production 52

The Premier Consulting Blog

AUGUST 21, 2024

August 2021: [link] Pharmaceutical Regulations in Japan: Drug Development: [link] [link] [link] Stability conditions for WHO Member States by Region, March 2021: [link]

Clinical Development 52

Clinical Development Pharmaceuticals Clinical Trials Trials 52

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Kalin was a partner in the global healthcare practice of McKinsey & Company, from 1990-2002. Before that, Ms.

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Clinical Trials Trials Production Therapies 40

LifeSciVC

DECEMBER 6, 2022

Darnell’s 2002 paper Transcription Factors as Targets for Cancer Therapy , in which he wrote: “A limited list of transcription factors are overactive in most human cancer cells, which makes them targets for the development of anticancer drugs.

Small Molecule 40

Small Molecule DNA Regulations Science 40

The Pharma Data

JUNE 18, 2021

Department of Health and Human Services FDA Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002. . Data on File, Allergan, 2016; Clinical Study Report Satisfaction Table. Data on File, Allergan; Neurotoxin Monthly Tracker Report, July 2017. . . . SOURCE AbbVie. Source link.

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Doctors FDA Approval Treatment Production 52

Metabolite Tales Blog

MARCH 1, 2023

2002, 15, 3, 269–299 [link] 2 Chem. There is much to be learnt from the pathways described above but in general, the more nitrogens present in your ring, the less likely you are to see Phase I type oxidations of the ring itself. Instead, be on the lookout for N -glucuronides. References 1 Chem. 2017, 30, 1, 13–37 [link] 2a Drug Metab.

Metabolic Stability 52

Metabolic Stability Drugs Pharmacokinetics Science 52

Science Daily: Pharmacology News

JANUARY 16, 2025

For example, incidence rates in women 50-64 years of age have surpassed those in men, and rates in women under 50 are now 82% higher than their male counterparts, up from 51% in 2002.

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Disease 286

Agency IQ

JULY 13, 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 ( see a Congressional Research Service report on its legislative history here ).

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FDA Packaging Laboratories Testimonials 40

Agency IQ

JUNE 7, 2024

Forty-eight Notified Bodies received designation for six codes, including software (MDA 0315), systems/procedure packs (MDS 1011), devices manufactured with metal (MDT 2001) or plastic processing (MDT 2002), devices with electronic components (MDT 2010) and devices requiring installation or refurbishing (MDT 2012).

Regulations 40

Regulations Compliance Packaging Production 40

Agency IQ

MARCH 25, 2024

Efforts to develop the DTC list were placed on hold from 2002 to 2013. As a result of legal challenges to other portions of section 503A, the FDA placed the development of the DTC list on hold in 2002. It was not until the passage of the DQSA in 2013 that the validity of section 503A was confirmed, and work could move forward.

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FDA Pharmacy Drugs Production 40