Drug Target Review

DECEMBER 14, 2023

In 2003, Dr Richard Wood, distinguished Professor at the University of Texas MD Anderson Cancer Center, was a crucial part of the first characterisation of polymerase theta. 2006 August 8 [2023 November 16]; 40: 363-83. Polymerase theta TMEJ has been the most elusive DNA repair pathway. This study was published in Nature.

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DNA Clinical Trials Treatment Research 59

Drug Target Review

JUNE 24, 2024

2023 June 26 [cited 2024 June]. In 2003, he was selected by EE Times as one of the top 13 most influential people in the semiconductor industry. News Medical & Life Sciences [Internet]. 2024 May 20 [cited 2024 June]. Available from: [link] ChatGPT. Available from: [link] Sara Merken. Reuters [Internet]. Medium [Internet].

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The Premier Consulting Blog

APRIL 27, 2023

In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. As of April 2023, the FDA is overseeing its eCTD v4.0 This group created the Common Technical Document (CTD), thereby standardizing applications submitted to regulatory authorities. and around the world, and eCTD v3.2.2, Currently, eCTD v4.0

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Packaging FDA International Pharmaceuticals 52

Common Sense for Drug Policy Blog

AUGUST 22, 2023

Drug Checking Services "One of the consequences of drug prohibition is the lack of knowledge regarding the composition and purity of illicit substances ( Miron, 2003 ; Taylor et al., dwf_admin Tue, 08/22/2023 - 17:07 Source Piatkowski T, Puljevic C, Francis C, Ferris J, Dunn M. 2023 Jul 21;119:104139. Int J Drug Policy.

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Drug Target Review

MAY 18, 2023

Results of the Multicenter Study of Hydroxyurea in Sickle Cell Anaemia published in the Journal of the American Medical Association in 2003, indicated that the use of hydroxyurea, the only drug approved at the time, reduced mortality as it reduced pain crises and increased foetal haemoglobin. cited 2023 May 11].

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FDA Law Blog: Biosimilars

MARCH 12, 2024

As we explained in September 2023 , then again in November 2023 , the FTC has intervened in the matter and asked 10 drug companies (really 8 given common ownerships of some of the relevant companies) to delist about 100 patents from the Orange Book that mainly cover the device constituent of a drug/device combination product.

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Agency IQ

NOVEMBER 20, 2023

EPA publishes draft Meaningful Involvement Policy The Environmental Protection Agency has released a draft of its Meaningful Involvement Policy, an update of a 2003 policy, which seeks to improve the interactions of the agency with stakeholders about agency actions. To contact the editor of this analysis, please email Patricia Iscaro.

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Regulations Government International Science 40

Perficient: Drug Development

OCTOBER 3, 2023

Bill has led marketing at Perficient since 2003, in a period of intense growth. We are proud to announce the expansion of our executive leadership team with the promotion of seven colleagues to senior vice president – Susan Adomite, Bill Davis, Ed Hoffman, Hari Madamalla, Santhosh Nair, Patrick Schwierking, and Kevin Sheen.

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Perficient: Drug Development

JANUARY 25, 2024

This is a disappointing reversal for payers, as the 2010 results showed a nine-point gain compared to the 2003 figure. But the 2023 results now put payers two points below where they stood 20 years prior. Push your own telemedicine solutions Telemedicine was a new addition to Gallup’s polling in 2023.

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Agency IQ

JANUARY 26, 2024

In 2003, the agency released Order 3120.5 , which focused on how to address plagiarism and fabrication within the agency, which handed the authority to investigate to the EPA’s Office of Inspector General (OIG). The policy will replace the 2012 SIP and reaffirm the role of the EPA’s SIO and deputy SIOs around the agency.

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Metabolite Tales Blog

MARCH 1, 2023

2023, 13, 1, 92- [link] 8 J. 2003, 31, 1240-1250 [link] 16 Drug Metab. Food Drug Anal. 2018, 26, 965-972 [link] 4a Pharmaceutics, 2022, 14, 1001 [link] 5 Phys. 2000, 2, 195-201 [link] 6 Biochem. 1966 98, 266-277 [link] 7 Metabolites. 2018, 61, 5, 2041–205 [link] 9 ACS Chem. 2019, 14, 2, 142–16 [link] 10 Chem. 1991, 21, 1179-1183.

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Metabolic Stability Drugs Pharmacokinetics Science 52

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. On March 21, 2023, the CHPA issued a press statement applauding the FDA’s actions. Read AgencyIQ analysis here. ].

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Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

JUNE 7, 2024

It’s clear that some designations have taken even longer, since so many Notified Bodies have received designation in 2022, 2023 and 2024, six or seven years after they could have applied for designation in November 2017. IVDR designations continues to lag behind MDR designations, as noted above.

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The Pharma Data

DECEMBER 10, 2020

The Company believes that the net proceeds from the Global Offering, together with its cash and cash equivalents, will be sufficient to fund its operations through the first quarter of 2023. Underwriting. The Global Offering is subject to an underwriting agreement entered into on December 10, 2020. 100.00%.

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Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. Regan, Case No: 1:15-cv-00512 (D.D.C.

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Common Sense for Drug Policy Blog

NOVEMBER 29, 2023

Strang, Beswick and Gossop, 2003 ; Wakeman et al. dwf_admin Wed, 11/29/2023 - 15:29 Source Robert Heimer, Anne C. Becker, Receipt of Opioid Use Disorder Treatments Prior to Fatal Overdoses and Comparison to No Treatment in Connecticut, 2016-17 , Drug and Alcohol Dependence, 2023, 111040, ISSN 0376-8716, doi.org/10.1016/j.drugalcdep.2023.111040.

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Common Sense for Drug Policy Blog

JUNE 4, 2023

2003 ) and strong results from RIOTT indicating improved outcomes for ‘treatment refractory’ people (i.e. dwf_admin Sun, 06/04/2023 - 20:04 Source Poulter, H. Despite a robust international evidence base for the social and health benefits of HAT ( Haasen et al., 2009 ; Perneger, Giner, del Rio, & Mino, 1998 ; Strang et al.,

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New Drug Approvals

JULY 10, 2023

g/mol BASE Vazegepant BMS-742413 BHV-3500 FDA APPR 3/9/2023 Zavzpret N -[(2 R )-3-(7-methyl-1 H -indazol-5-yl)-1-[4-(1-methylpiperidin-4-yl)piperazin-1-yl]-1-oxopropan-2-yl]-4-(2-oxo-1 H -quinolin-3-yl)piperidine-1-carboxamide ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. 10 March 2023.

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Clinical Trials Treatment Trials FDA 40

FDA Law Blog: Biosimilars

AUGUST 29, 2024

But like cockroaches, some pieces of legislation are resilient and never seem to die. 3) A covenant not to sue on any claim that the ANDA product or biosimilar biological product infringes a United States patent.

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Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. Interfaces , 2023. Tom Ough writes about how UVC light, metals, and surface coatings can help fend off pathogens for Issue 01. Read it on our website here. The man was in Hong Kong for kidney treatment. Credit: Qi S.

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Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC, LAURA DIANGELO, MPH MAY 30, 2023 9:39 PM CDT Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely. OIRA eventually released the rule for release by the FDA (with changes) on May 10, 2023.

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Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. EPA plans to publish the final rule in 2023.

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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. The Fall 2022 edition was released in January 2023. June 2023 may be a busy month for the agency.

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Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. EPA’s FIP was due January 7, 2021.

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Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. EPA’s FIP was due January 7, 2021.

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Agency IQ

MARCH 1, 2024

The rule was sent to OIRA on December 15, 2023, meaning that it will likely be released in mid-March if OIRA sticks with its typical 90-day review schedule. OIRA received the rule on December 6, 2023, therefore in keeping with the 90-day review, the final rule could be released in early March.

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Drug Target Review

OCTOBER 4, 2023

10 Proteasome inhibitors Since the approval of Bortezomib in 2003, 11 new proteasome inhibitors have emerged with reduced side effects. Hematol Oncol 16 , 3 (2023). 66 , 10715–10733 (2023). 12 PROTACs PROTACs form part of an exciting addition to the ADC family: the degrader-antibody conjugates (DACs). Duvall J R, et al.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. Attorney Merrick Garland and DEA Administrator Anne Milgram, from Michele Leonhart, et al., (Oct.

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Regulations Production FDA Approval Drugs 59

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. DEC 7, 2023 10:01 PM CST Some things to know: The Unified Agenda is released twice each year, as “Spring” and “Fall” versions.

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Agency IQ

MARCH 29, 2024

The rule was sent to OIRA on December 15, 2023, meaning that it will likely be released in mid-March if OIRA sticks with its typical 90-day review schedule. OIRA is currently reviewing the EPA’s proposed rule that would set the first federal enforceable limits for six different PFAS in drinking water.

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Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Refstad, 2003 ) but were rarely detected in our sample ( n= 3), the last time in 2012. Sevigny, Sylvia Thyssen, Earth Erowid, Russell Lea, Misrepresentation of MDMA in the United States, 1999–2023 , Drug and Alcohol Dependence, Volume 264, 2024, 112467, ISSN 0376-8716, doi.org/10.1016/j.drugalcdep.2024.112467. 2024.112467.

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Codon

APRIL 8, 2025

Proteins designed by David Baker’s laboratory, 2003-2023. However, despite rapid progress in the field of protein biology, “core” features of these molecular machines — how they fold, how they change shape, and how simple strings of amino acids can yield forms of incredible complexity — remain unknown.

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RNA DNA Laboratories Virus 89

Agency IQ

FEBRUARY 2, 2024

November 2023 Clean Water Act Methods Update Rule for the Analysis of Effluent (Final Rule Stage) 2040-AG25 OW regularly promulgates updates to the table of approved Clean Water Act (CWA) monitoring methods at 40 CFR 136.3. This routine Methods Update Rule (rMUR) was proposed in February 2023.

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Regulations Compliance Engineering Government 40

Agency IQ

JANUARY 4, 2024

BY WALKER LIVINGSTON, ESQ | DEC 20, 2023 12:09 PM CST What we expect to be talking about in January Particulate matter. Such a review will assess whether the use may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the chemical substances subject to this SNUR.

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Regulations Government Compliance Science 40

Codon

NOVEMBER 1, 2024

A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people. bioRxiv (2023). Department of Energy and National Institutes of Health initiated a 15-year plan to map ‘the sequence of all 3.2 billion letters’ of DNA within the human genome. Credit: Shaib A.H.

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Drug & Device Law

MARCH 4, 2024

3d , 2023 WL 8711617 (S.D.N.Y. 18, 2023), some late-arrival plaintiffs in that litigation sought a do-over, which is now being litigated. 2023) (denying do-over not an abuse of discretion; “allowing plaintiffs to designate a new expert would prejudice defendants”). 2023 WL 5322213, at *6 (6th Cir. 3d 480, 495 (Cal.

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