The FDA Law Blog

NOVEMBER 11, 2024

As those of us of a certain age remember, prior to 2005/2006, pseudoephedrine was the decongestant of choice for OTC multi-symptom cold medicine. Then, Congress passed, and the President signed the Combat Methamphetamine Epidemic Act of 2005. a); OTC Monograph M012: § M012.20. a); OTC Monograph M012: § M012.20.

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STAT

JUNE 29, 2023

In 2005, Nick Voyles was diagnosed with hepatitis C after being released from five years of incarceration. A nurse told him he had only six months to live. He was prescribed a drug cocktail, a combination of interferon and ribavirin, that proved ineffective and gave him severe side effects. recalled.

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PioneerRx

AUGUST 17, 2022

The journey to discovering her niche began in 2005 when her brother, a pharmacist, chose to pursue a career… For Stacy Welling, business has always been personal.

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PioneerRx

AUGUST 17, 2022

The journey to discovering her niche began in 2005 when her brother, a pharmacist, chose to pursue a career… For Stacy Welling, business has always been personal.

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STAT

FEBRUARY 13, 2023

He was the eighth most highly-cited researcher in life sciences and medicine for the decade of 1995 to 2005, according to the Thomson Corporation. Prior to that, he was the CEO of the Sanford-Burnham Medical Research Institute in La Jolla, Calif., and a leading researcher in cell biology. Continue to STAT+ to read the full story…

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STAT

SEPTEMBER 6, 2022

To motivate prescribing, Bayer illegally paid kickbacks to physicians, according to the lawsuit filed in 2005 by a former Bayer marketing employee (see here and here ). One lawsuit alleged that the company deliberately downplayed risks and overstated benefits of Trasylol, which is used to control bleeding in certain heart surgeries.

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Hospitals 97

PQA

FEBRUARY 16, 2024

He was kind, generous and thoughtful in his support of PQA and its mission.Kelman joined CMS in 2005 and helped implement the Part D program. Kelman served on the PQA Board of Directors for 10 years and most recently served on the board as a CMS Special Advisor. Kelman was a trusted advisor to PQA since its establishment in 2006.

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STAT

SEPTEMBER 26, 2023

The last time Elevance successfully brought a Blues plan under its giant investor-owned wing was in late 2005 , when it acquired New York City-based WellChoice. Lawmakers in August urged Blue Cross to put the deal on ice, and last week, Louisiana’s attorney general hinted at legal action if the company didn’t do so.

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STAT

JUNE 25, 2024

The justices threw out a lower court ruling that revived a lawsuit brought by the military personnel and civilians who said they were harmed between 2005 and 2011 in the Iraq war. The justices asked the lower court to reconsider the case.

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The People's Pharmacy

MAY 21, 2023

From about 1985 till about 2005, my blood pressure ran about 150/90 and I needed antihypertensive medications. 2005; Journal of Agricultural and Food Chemistry , March 8, 2006). But they often overlooked an important fact: grapefruit itself can have beneficial effects for human health. Grapefruit Lowers Blood Pressure: Q.

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The FDA Law Blog

SEPTEMBER 26, 2023

Since I entered the life sciences industry in 2005, I’ve respected HP&M and admired their expertise and elite standing,” said Grizzel. “I Ellison, HP&M’s Managing Director. I’m incredibly excited by the opportunity to work for HP&M and its amazing group of professionals.

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FDA 57

The FDA Law Blog

AUGUST 21, 2023

Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). We note that in December 2020, the same U.S. 2, 2020 ( DOJ Press Release ). 21 U.S.C. § 830(e)(1)(B)(i).

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Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

Hospital Pharmacy Europe

SEPTEMBER 4, 2024

Researchers from University College London Hospitals NHS Foundation Trust analysed data from patients with heart failure in UK Clinical Practice Research Datalink between 2005 and 2021.

Hospitals 52

Hospitals 52

ISPE

JUNE 15, 2023

2005 “Enterprise-Control System Integration Part 3: Activity Models of Manufacturing”) is often misinterpreted to define specific systems for each level. The ISA95 hierarchical model (depicted by the following ISPE figure based on ANSI/ISA 95.03-2005 This model is a functional hierarchy. Adapted from: ANSI/ISA 95.03-2005.

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pharmaphorum

AUGUST 12, 2020

Author and journalist John-Manuel Andriote has spent much of his career writing about the impact of HIV/AIDS – a job that became much more personal when he himself was diagnosed in 2005. Then in 2005, three weeks after his 47th birthday, an annual physical checkup changed John’s life forever. “I I had no warning.

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pharmaphorum

JULY 6, 2021

The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million record set by Immunocore in 2005.

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Documentation Vaccines 141

Hospital Pharmacy Europe

OCTOBER 3, 2024

In September, FIP also updated its 2005 statement of policy on the role of pharmacists in access to safe and quality medicines , stating that ‘governments should ensure that access to medicines and medical devices is always accompanied by access to pharmacists and pharmaceutical expertise’.

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Hospitals Documentation 52

pharmaphorum

NOVEMBER 1, 2021

It is the first oncolytic virus therapy to be launched anywhere in the world for brain cancer, and only the third oncolytic virus therapy to be made available to patients worldwide, after Shanghai Sunway Biotech’s Oncorine for nasopharyngeal carcinoma in 2005 and Amgen’s Imlygic (talimogene laherparepvec) for melanoma 10 years later.

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Pharmaceutical Technology

OCTOBER 10, 2022

In 2005, Boostrix was approved by the FDA as a single dose to boost immunisation against pertussis, tetanus, and diphtheria in individuals aged 10 years to 18 years. “While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series.

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Vaccines FDA 59

European Pharmaceutical Review

OCTOBER 10, 2022

The FDA initially approved Boostrix in 2005 as a vaccine to protect against Tdap in patients from 10 years old to 18. The endorsement therefore demonstrates significant progress in the industry’s ability to combat the disease in the younger population.

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Vaccines FDA 105

pharmaphorum

JANUARY 21, 2021

Aurora was founded in 2005 by Claire Eldridge and Neil Crump and has recently launched a sister consultancy, Atlas. This supports clients to connect with patients and advance products and services through strategy, co-design and organisational change services.

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Communication 52

pharmaphorum

FEBRUARY 23, 2022

The case concerns actions allegedly taken by Servier between 2005 and 2007, in which the pharma company entered into “pay for delay” agreements with four generic drugmakers to stall competition for its blockbuster anti-hypertension drug perindopril (brand name Coversyl).

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European Pharmaceutical Review

MARCH 15, 2023

Tomáš Pluskal from IOCB Prague has coordinated the project almost since its inception in 2005. A worldwide community of researchers was formed and the software continued to expand its functions. The greatest strength of the MZmine project is the international community of experts that has formed around the project.”

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Compounding 139

The Checkup by Singlecare

DECEMBER 14, 2023

Sources Community-acquired urinary tract Infection by Escherichia coli in the era of antibiotic resistance , BioMed Research International (2018) Urinary tract infection , Centers for Disease Control and Prevention (2021) Amoxicillin , StatPearls (2022) Uncomplicated urinary tract infections , StatPearls (2023) Beta-lactam antibiotics , StatPearls (..)

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The Checkup by Singlecare

JULY 14, 2023

Norgestrel was approved by the FDA for prescription use in 1973 , but it hasn’t been available since 2005 due to business reasons for the manufacturer. In a July 13 statement , Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America, applauded the move: “Birth control is essential health care.

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pharmaphorum

JANUARY 28, 2021

In two phase 3 trials – CALGB 100104 and IFM 2005-02 – Revlimid given as a daily oral dose after a stem cell transplant was able to extend the time patients survived without disease progression compared to placebo. The drug has been approved for this use by the Scottish Medicines Consortium (SMC) since last September.

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The FDA Law Blog

JUNE 11, 2023

This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.”

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Labelling FDA 40

Hospital Pharmacy Europe

OCTOBER 31, 2022

developed incident AF during the period of study from 2005 to 2015. In a total of 23,561,884 individuals, 98,271 used methamphetamine, 48,701 cocaine, 10,032 opiates and 132,834 cannabis. From this total, 4.2% The mean age of participants ranged from 32.3 years (cannabis) to 41.1 cocaine) and the proportion of females from 28.3%

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Hospitals 72

European Pharmaceutical Review

OCTOBER 2, 2023

Through [their] discoveries, Karikó and Weissman opened up opportunity for the pharmaceutical industry to advance mRNA technology” These data were published in 2005, fifteen years before the COVID-19 pandemic, of which mRNA vaccines were instrumental to controlling.

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pharmaphorum

OCTOBER 7, 2022

Starting with the primary care era of 1997-2005, when key launches were primary care blockbusters, such as Losec, Diovan, and Lipitor, IQVIA took five key therapy classes from that era that consistently appeared in the top 10 therapy area by sales for the time period of the era.

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FDA 88

The Checkup by Singlecare

JUNE 24, 2024

For example, a 2005 study looked at three groups of people: those who took cyclobenzaprine alone, those who combined 400 mg of ibuprofen with cyclobenzaprine, and those who combined 800 mg of ibuprofen with cyclobenzaprine. However, research suggests the combination is not more effective than either drug taken alone.

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Pharma Marketing Network

MAY 3, 2023

As such, it is important for the industry to carefully consider the effects of these advertisements and to take steps to ensure that they are promoting the right messages in the right ways. References: 1. Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. Knopf Doubleday Publishing Group. Goozner, M. Steinman, M.

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Hospital Pharmacy Europe

MARCH 7, 2024

Many oncology drugs approved by the European Medicines Agency (EMA) between 2005 and 2020 provide ‘little or no added benefit’ for patients, according to new research. This was particularly true for medications that had ‘fast-tracked’ approval pathways, the Dutch researchers said.

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The People's Pharmacy

JUNE 19, 2023

Some people have reported that dark chocolate may calm a cough. Research in guinea pigs shows that the cacao compound theobromine can suppress the cough reflex ( Usmani et al, FASEB Journal , Feb. 16, 2017 ).

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Compounding 64

Hospital Pharmacy Europe

OCTOBER 13, 2022

Other data provide a similar picture with a 2005 retrospective analysis of 90 patients older than 50 years of age, finding that the use of aspirin, clopidogrel, or a combination, significantly increased the risk of mortality when head injury involves intracranial haemorrhage.

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Hospitals 52

pharmaphorum

NOVEMBER 27, 2020

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. The deal was agreed well before Teva bought Cephalon in 2011 for $6.8 billion and involved a complex series of transactions instead of an up-front payment.

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Packaging Documentation 52

The People's Pharmacy

MAY 8, 2023

Ever since 2005, recurrent urinary tract infections (UTIs) have troubled me. A recent analysis of all the studies done on cranberry juice preventing urinary tract infections confirmed this ( Cochrane Database of Systematic Reviews , April 17, 2023 ). Might there be a benefit from cranberry pills? Reader Reaps Benefit from Cranberry Pills: Q.

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