Agency IQ

SEPTEMBER 15, 2023

In 2007, an FDA advisory committee weighed phenylephrine’s GRASE status, prompted by a Citizen Petition questioning its effectiveness In December 2007, the FDA’s Nonprescription Drugs Advisory Committee met to discuss the efficacy of phenylephrine 10 mg , the oral dosage approved for OTC use.

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The Pharma Data

FEBRUARY 1, 2021

.” But Bennett, who was still playing more than a hundred dates a year when he married Susan in 2007 at age 80, noticed something was wrong during a 2015 tour, AARP reported. He wanted to see a doctor. He told Susan he couldn’t remember the names of the musicians on stage. She thought it was normal aging.

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The Pharma Data

JANUARY 21, 2021

In the current study, three patients died after their transplant, though none occurred after 2007. The trick, according to Rae-Grant, is to strike a balance: Doctors would not want to be overly aggressive in using stem cell transplants, but would also want to intervene early enough to forestall disability as much as possible.

Therapies 52

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FDA Law Blog: Biosimilars

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.” Plainly, the Government brief states “The decision below is incorrect.

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The Pharma Data

DECEMBER 8, 2020

. “I think anyone who’s been a fan of rap music across the last two decades — myself included — had a feeling this was happening,” said study author Alex Kresovich, a doctoral fellow in the Hussman School of Journalism and Media at the University of North Carolina at Chapel Hill.

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Broad Institute

AUGUST 2, 2023

He has had continuous NIH funding for the past 25 years and was Director of the Academy of Finland Centre of Excellence in Complex Disease Genetics (2007-2011). He has supervised 52 PhD students and received the Maud Kuistila award for excellence in doctoral training. He held an Academy of Finland professorship for 2013-2017.

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The Pharma Data

MAY 14, 2021

That doctors can’t help was certainly the last straw. Although when I first went to my doctor I didn’t realize this at all. My doctor told me she suspected I had fatty liver disease. I’d gone to the doctor feeling tired. I was going to find out which were the most effective meds and then speak to my doctor about them.

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PLOS: DNA Science

OCTOBER 5, 2023

Listen to doctors, do research, then finally decide. Since 2007, a nationwide army of talented volunteers has made these soft boob replacements and donated them to women with BC. I took the most drastic action – I had reason to believe my case was worse than the others.

DNA 79

DNA Treatment Science Doctors 79

The Pharma Data

MAY 14, 2021

Billions of Rubles were spent in this “think-tank” of Olympic Coaches, Special Forces Trainers, Psycho-Physiologists and Biomechanics Researcher Doctors. When you do get out of breath, faster than even a world-class fighter, you’ll recovery your heart rate and amaze your doctors! relaxed and awaken totally refreshed!

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The Pharma Data

NOVEMBER 10, 2020

Combined with real-world study (RWS) as well as medical theories and clinical cases, the monograph concludes, from the perspective of medical treatment, the experience of doctors in various regions of China in exploring the application of hydrogen-oxygen adjuvant therapy in mild, moderate, severe and critical patients at the baseline level.

Hospitals 52

Hospitals Clinical Trials Treatment Therapies 52

FDA Law Blog: Biosimilars

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.

FDA Approval 40

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Drug Discovery World

FEBRUARY 15, 2023

2007) 26:29–48. Originally qualifying as a medical doctor specialising in immunology, he went on to train as a pathologist and immunologist, before completing a PhD in molecular medicine. Cancer immunotherapy: historical perspective of a clinical revolution and emerging preclinical animal models. Front Immunol. 2017) 8:829.

Research 130

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Drug & Device Law

MARCH 31, 2022

We discussed these concerns – which have since crystallized into what is called either the “municipal cost recovery rule” or the “free public services doctrine” – more detail back in one of the Blog’s early(2007) posts. The first part is rational, restrained, and full in accord with governing precedent.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” Best Pharmacal , 577 P.2d Robins Co. ,

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Drug & Device Law

FEBRUARY 28, 2022

2007), for similar reasons. “[A]n Internet Google search that revealed one case report,” combined with “temporal proximity,” was not sufficient grounds to “rule in” the defendant’s drug for purposes of “differential diagnosis.” Dec. Exclusion of expert testimony was affirmed in Ervin v. Johnson & Johnson, Inc. , 3d 901 (7th Cir.

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Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 23 in its current form. at *3) Rule 23(c)(4) partial class.

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Drug & Device Law

MAY 26, 2023

They can regulate doctors, pharmacies, and grocery stores, but cannot ban an FDA-approved drug like they can pork that comes from pigs not raised in a specific way, the gist of the California law at issue in NPP. Likewise, states cannot ban a drug that FDA has approved, including ones that once were considered street drugs.

Regulations 59

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Drug & Device Law

JUNE 6, 2022

Further, “both doctors testified that they still prescribe [the drug] for patients with conditions similar to plaintiff’s condition.” 2007 WL 2526402, at *3 (D. 2007 WL 5861354, at *4 (C.D. 2007 WL 5861354, at *4 (C.D. Schering Corp. , 2d 1140, 1148 (N.J. 1993) (dissenting opinion). at 1233 (citation omitted).

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Drug & Device Law

MAY 19, 2023

In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone. First, relief was not dependent on “third-party action” – that of prescribing physicians and intermediate distributors. at *6 (citations omitted).

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Drug & Device Law

JULY 28, 2023

19, 2021) involving a plaintiff who had implant surgery in 2007 (discussed here ). For instance, the court found persuasive plaintiffs’ argument that that “[i]t would be quite difficult” for plaintiffs “to know what misrepresentations [the defendant] made to their doctor.” Smith &Nephew, Inc. LEXIS 157412 (D.

Trials 52

Trials Doctors Production Research 52

Drug & Device Law

MAY 26, 2022

After attending a patient education class, seeking a second opinion, being warned that she was at increased risk for revision as a woman, and being warned of a risk of metal ions accumulating in her blood, she went forward with the BHR implant in her left hip on June 25, 2007. at *7 (citing the case discussed here ).

Doctors 59

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Drug & Device Law

DECEMBER 11, 2023

Defendant] does not deny that it, the doctor, and the hospital are potential joint tortfeasors. . . . Implantable Defibrillators Products Liability Litigation , 2007 WL 2572048, at *2 (D. 30, 2007) (“joinder of the malpractice claim. . . Synthes Corp. , 16, 2010); In re Guidant Corp.

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Drug & Device Law

NOVEMBER 14, 2023

2007); Pappas v. 2007); Foister v. All connections alleged were with [the lead defendant] and his doctors. Raddatz , 895 P.2d 2d 633, 637-38 (Mont. 1995); Lastrina v. Bettauer , 289 A.3d 3d 1222, 1234 (Conn. 2023); Gentile v. Malenick , 112 N.Y.S.3d 3d 364, 365 (N.Y.A.D. 2019); Kaminer v. Eckerd Corp. , 2d 452, 454 (Fla.

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Drug & Device Law

OCTOBER 26, 2023

Indeed, one of Bexis’ very first blogposts , back in 2007, was a comprehensive review of non-preemption defenses to negligence per se. The very first non-preemption defense to negligence per se mentioned in Bexis’ 2007 post was legislative intent. Bexis’ 2007 post , though dated, is a good place to begin that familiarization.

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