FDA Law Blog

JULY 11, 2023

Approved in 2007 for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy, with several indications added in the subsequent years, Somatuline Depot is a synthetic octapeptide available as ready-to-use prefilled syringes for deep subcutaneous injection.

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IT Specialization Patients 95

GeriPal

JUNE 26, 2025

-Alex Smith Additional links mentioned by Tsai-Chin Cho: – Wealth shocks and mortality in the US – Change in marital status as a risk for wealth shock ** NOTE: To claim CME credit for this episode, click here ** Transcript Eric 00:11 W elcome to the GeriPal p odcast. This is Eric Widera. Alex 00:12 This is Alex Smith. Is it you, Rebecca?

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Illness Hospital IT Patient-Centered 52

PEMBlog

AUGUST 14, 2024

2007 Mar;8(2):115-31. What is Dexmedetomidine? Dexmedetomidine, often known by its brand name Precedex, is a fascinating medication. It’s a highly selective central alpha-2 agonist that’s able to induce a state of sedation that closely mimics natural sleep. Plus, it’s versatile! Curr Opin Anaesthesiol. 2008 Aug;21(4):457-61. doi: 10.1097/ACO.0b013e328305e3ef.

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Patients IT Medical Management 59

PEMBlog

JUNE 14, 2023

Children’s Mental Health Emergency Department Visits: 2007-2016. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what we should consider when boarding children in the ED for mental health reasons. Pediatrics. 2021;147(5):e2020030692. doi: 10.1542/peds.2020-030692

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Mental Health Management Patient-Centered Illness 98

PEMBlog

MAY 17, 2023

J Inherit Metab Dis 2007; 30:631. Why then do we persist with the “is it medical/organic or psych” question? It is also episode 1 in a 5 episode series focused on agitation in children and adolescents. Collaborative Care in the Identification and Management of Psychosis in Adolescents and Young Adults. Pediatrics 2021; 147.

Patient-Centered 71

Patient-Centered Mental Health Management Finance 71

CDOCS

NOVEMBER 17, 2021

We&rsquo;ve been helping people afford their dentistry since 2007 and currently work with over 23,000 providers nationwide. </span></p> <p><span style="font-size:14px;">A. LendingClub Patient Solutions is one of the most trusted names in dental financing.

Finance 52

Finance Patients Treatment Plan Management 52

FDA Law Blog

AUGUST 12, 2024

FDA also consistently interpreted it that way between 1990 and 2007. The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. FDA guidance has been clear that that point for rolling submissions is when the last component has been submitted. While Nissan et al.

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Provider IT Consulting Medical 59

FDA Law Blog

APRIL 30, 2023

Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. That bill is S. 112-144 (2012). With that background, let’s get back to S.

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IT Education Patients Provider 59

FDA Law Blog

MAY 3, 2021

By McKenzie E. Cato & Michelle L. On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The notice was given to Acceleron Pharma, Inc., The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S.

Clinic 52

Clinic Patient-Centered IT Provider 52

FDA Law Blog

SEPTEMBER 30, 2022

47 (2007), which addressed the intent standard under the Fair Credit Reporting Act. The relator has until December 22, 2022 to petition for certiorari to the Supreme Court. Apart from its importance in connection with best price stacking, the Sheldon case has been cited in a larger controversy about the intent standard under the FCA.

Insurance 40

Insurance Manufacturing Government Specialization 40

FDA Law Blog

MAY 3, 2021

By McKenzie E. Cato & Michelle L. Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The notice was given to Acceleron Pharma, Inc., The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S.

Clinic 40

Clinic Patient-Centered IT Provider 40

CDOCS

MARCH 15, 2021

important;" xml:lang="EN-US">In 2007, a few of us were sitting at dinner when the CEO of our company at the time, Mr. Imtiaz Manji, came up with an idea for the cerecdoctors.com Magazine. Sometimes, however, it&rsquo;s difficult to leave the old ways behind.&

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Family Families Education Community 52

The Health Policy Exchange

MAY 20, 2013

Although a 2007 meta-analysis first sounded the alarm about rosiglitazone's cardiovascular risks, the manufacturer successfully stalled regulatory action in the U.S. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple.

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Manufacturing Family Medicine DO Patients 130

CDOCS

MARCH 26, 2021

png]<br /> <em><span style="font-size:11px;">​Figure& 1:& <span data-contrast="auto" xml:lang="EN-US">A life-long bruxer, this patient presented with lost teeth in the posterior and compensatory eruption of lower anterior teeth.</span>&

Families 52

Families Family Patients Provider 52

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. It’s not surprising that the number of repeat calls for falls is alarmingly high. Alex: I think this is a first.

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Community Transportation IT PCP 116

GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

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IT Patient-Centered Illness Education 127

GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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Board-Certified IT Community Medical Student 91

FDA Law Blog

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” The Government’s brief puts a lot of faith in the existing regulatory system rather than the patent system.

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Government Manufacturing IT Utilities 72

GeriPal

FEBRUARY 17, 2022

When we have a medication with up front harms and downstream benefits, it’s critical that we consider the time to benefit, or how long it will take an individual to benefit from a test or treatment. Think of the 10 years it takes to benefit from colon or breast cancer screening, which is designed to detect slow growing cancers. See screenshot below.

Clinic 68

Clinic IT Patients Medical 68

GeriPal

AUGUST 11, 2022

Myself personally, I was in PCEP at Harvard, I think like 2007 or something with Rachelle Bernacki and a bunch of other great people. Alex: Today, we are truly honored to welcome Susan Block, who is the founder of the department of psychosocial oncology at the Dana-Farber Cancer Institute in the Brigham and Women’s Hospital in Boston.

Illness 110

Illness IT Families Family 110

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. Racial/Ethnic and Geographic Trends in Combined Stimulant/Opioid Overdoses, 2007–2019. link] Townsend, T., Rivera-Aguirre, A., Bunting, A. Marshall, B. Martins, S. S., & Cerdá, M.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

SEPTEMBER 12, 2024

Well-being committees are popping up at every level of an organization. And C-suites now have chief wellness officers sitting at the table. Eric 01:54 Why’d you pick this song, Naomi? Naomi 01:57 Because it really talks about this beautiful experience of our beloved, which is ourselves, the part that we often cut out of the equation.

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IT Healthcare Healthcare Professional Patient-Centered 112

GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Joel: Yeah, right, I Will Remember You, right. Alex: … Sarah McLachlan.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

PEMBlog

MAY 24, 2023

2007 Oct;14(5):265-8. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children. It is also episode 2 in a 5 episode series focused on agitation in children and adolescents. West J Emerg Med.

Management 55

Management Patient-Centered Physicals Finance 55

FDA Law Blog

JULY 11, 2021

DEA previously authorized MNTPs to dispense remotely on an ad hoc basis, and placed a moratorium on new authorizations in 2007. By Larry K. Registration Requirements for Narcotic Treatment Programs with Mobile Components , 86 Fed. Only the registered NTP can supply narcotic drugs to their MNTPs.

Transportation 52

Transportation Patient-Centered Medical Patients 52

FDA Law Blog

FEBRUARY 4, 2025

The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies. Below, we discuss some of its downstream impacts on the PRV landscape.

IT 52

IT Vaccination Manufacturing Medical 52

FDA Law Blog

SEPTEMBER 6, 2021

Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired. Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs.

IT 52

IT Provider ER Insurance 52

FDA Law Blog

AUGUST 21, 2023

FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. Koblitz & Deborah L. More than a few have taken far longer—literally decades.

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Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law Blog

MAY 19, 2022

CMS argued that the harm PhRMA members allege cannot be traced to this rule, but rather to CMS’s 2007 and 2016 rules that included an obligation to account for accumulator programs in BP calculations. District Court granted PhRMA’s motion for summary judgment and struck down the final rule, holding that it exceeded CMS’s statutory authority.

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Manufacturing Patients Insurance Government 40

FDA Law Blog

MAY 26, 2025

118, 129 (2007) (quoting Abbott Labs v. Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. MedImmune, Inc. Genentech, Inc., Gardner , 387 U.S. 136, 152 (1967)). There are at least two issues with DOJs planned use of the statute. Specifically, in United States v. Nagarwala , 350 F.

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Manufacturing Provider Medical IT 59