Eye on FDA

AUGUST 16, 2023

To view the former, you can go to this page and see the Untitled Letters issued each year. If you want to see Warning Letters, you must go the Warning Letters page and perform a search specific to the issuing office – Office of Prescription Drug Promotion. Photo by Goh Rhy Yan at Unsplash

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Sales Doctors Doctor Medicine 84

Rethinking Clinical Trials

OCTOBER 10, 2023

The objective of the study is to evaluate 2 strategies grounded in behavioral economic theory and implementation science to increase ABCDEF bundle adoption and, in turn, address known health disparities in the ICU. Ethics and regulatory documentation for all of the Demonstration Projects is available on our Data and Resource Sharing page.

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Trials Clinical Trials Clinical Trials 141

World of DTC Marketing

APRIL 6, 2022

Challenge #2 – UNDERSTANDING YOUR AUDIENCE – Pharma marketers don’t get a drink of water without doing research, but the analysis they are getting is too quantitative. When I submit my creative brief to a client, there is a page headline “what do we know about our target audience and caregivers?”

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Marketing Sales Pharma Companies Doctors 196

Intouch Solutions

NOVEMBER 17, 2021

In mid-August, SEO professionals across all industries began noticing a significant shift in search engine result page (SERP) listings. Before we dive into the details, let’s get grounded on some key definitions: SERP – This refers to a search engine result page, which is what you see after you search, and before you click on a result.

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Marketing Engineer Branding 52

Pharma Marketing Network

DECEMBER 6, 2021

Direct Integrations with hundreds of leading health websites provides Tap Native access to billions of content pages for analysis. Tap Native analyzed visits to health and medical content pages across dozens of health websites where consumers seek answers to their most important health questions. Beauty topics, skin health, hair loss.

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Engineer Vaccination Vaccine Production 52

FDA Law Blog

MARCH 13, 2024

Karst — After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. And we even throw in Part 3½ in homage to the 1992 comedy “ The Naked Gun 2½: The Smell of Fear ” starring Leslie Nielson as bumbling Police Lt. Though we keep looking over our shoulder.)

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Marketing Production FDA Approval Generic Drugs 59

World of DTC Marketing

JUNE 24, 2021

Safety pages on Pharma product websites continue to have high utility. It turns out that after all these years, traditional TV viewing (over-the-air and cable) account for about 2/3 of all TV viewing and streaming accounts for only about 25%. SUMMARY: Consumers don’t real pay attention to fair balance in TV ads.

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Doctors Doctor Production Drugs 165

Camargo

SEPTEMBER 8, 2021

Prior to the enactment of the Hatch-Waxman Amendments, which established the current abbreviated new drug application (ANDA) and the 505(b)(2) application, some drug products were approved through an ANDA that was in many ways a less rigorous NDA: These pre-Hatch-Waxman applications are now called PANDAs. Co-Authors: Ken Phelps.

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Development Regulation Production Drugs 186

World of DTC Marketing

SEPTEMBER 17, 2020

Obesity has serious health consequences including increased risk for type 2 diabetes, high blood pressure, stroke and many types of cancers. Pharma should include warnings about obesity on every drug product page that could be caused by obesity.

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Production Drugs 242

The Pharma Data

DECEMBER 29, 2020

months; epoch 2). months; epoch 2). “There was no meaningful difference between pregnant women and nonpregnant women in increased seizure frequency during epoch 1 as compared with epoch 2,” the authors write. TUESDAY, Dec. 24 issue of the New England Journal of Medicine. Pennell, M.D., Pennell, M.D.,

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Medicine Drugs Research 52

FDA Law Blog

AUGUST 21, 2023

2, 2020 ( DOJ Press Release ). Regulated sellers must train employees on SCLP sales requirement content developed by DEA and listed on the DEA website provided at the Diversion Control Division Retail Training Page. 21 U.S.C. § 830(e)(1)(B)(i).

Pharmacy 52

Pharmacy Regulation Sales Production 52

Camargo

JUNE 9, 2021

The hamster is currently experiencing a rise in popularity as an animal model for SARS-CoV-2 studies , as it models the pulmonary pathology and viral load characteristic of human COVID-19 cases. To learn more, subscribe to our insights at the bottom of this page, and get notified when our upcoming blog post on DART studies goes live.).

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Reagent Production Drugs Allergies 178

Camargo

AUGUST 11, 2021

Differences in the approval process and formal meetings or scientific advice processes between the US and EU will be discussed in this post, while Part 2 will cover applications for conducting clinical studies, expedited programs, pediatric considerations, and labeling. prior to scheduled date of meeting or of WRO 2 response time).

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Production Packaging Packaging Marketing 230

Rethinking Clinical Trials

OCTOBER 19, 2022

Identifying Those Engaged in Research : Clinical research routinely involves 2 distinct roles: researchers and research participants. Navigate the new collection by using the “Ethics & Regulatory” drop-down menu on any page of the Living Textbook at rethinkingclinicaltrials.org.

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Clinical Trials Clinical Trials Trials Regulation 100

Intouch Solutions

JUNE 27, 2023

Engaged Sessions – Engaged Sessions is the number of sessions that last 10 seconds or longer or have 1 or more conversion events* or 2 or more page or screen views.​ Sessions – The metric is calculated in a different way to dedupe users and could result in sessions appearing deflated compared to Universal Analytics.

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Marketing Branding Development 98

Cloudbyz

JUNE 2, 2020

Instead of having to navigate to the Reports tab, search for your report, and add the record as a filter, the same can be achieved straight from the record page. You will be taken to the following screen: Step 2: Adjust and add new filters. The report URL that you copied in Step 2 needs to be pasted in the canvas.

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Production 55

FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The District Court spent 30 pages of its 38 page opinion detailing exactly why the Court has standing to adjudicate the aggrieved Plaintiffs’ claims, which standing arguments were briefed in excruciating detail by the government.

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Pharmacy Production Drugs Regulation 98

Cloudbyz

AUGUST 11, 2023

A clear channel ensures everyone’s on the same page. Detailing the Site Initiation Visit (SIV) Plan An effective SIV is like a pre-flight checklist: Protocol Refresher: It’s essential to reiterate the protocol to ensure everyone’s on the same page.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Velocity Clinical Research

JUNE 16, 2023

Participants responded best to fewer attempts at contact, preferring the “1-2 attempts” (50%) over the “Call until you reach me” (25%) and “3-4 attempts” (12%). The idea of a condensed, two-page quick-reference version of the document also came up. Contact Frequency: Less is more.

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Compliance Clinical Research Clinical Trials Clinical Trials 52

WCG Clinical

NOVEMBER 3, 2023

In stage 2, subjects tested the usability of the eDiary, including the ease with which they could navigate and use it. add date to “My tasks” page) and formatting (e.g., Both stages adhered to regulatory emphases on incorporating the patient perspective and aligning with Patient-Reported Outcome (PRO) development best practices.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Development 52

World of DTC Marketing

JANUARY 20, 2022

Eighty-nine percent of health seekers who visit multiple sites say that, in general, they start at a place like Yahoo or the AOL home page. The typical range of sites visited is two to five. Just 8% of health seekers who visit numerous sites say they are most likely to start at a specialized health site like WebMD.com.

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Doctors Doctor Branding Marketing 232

pharmaphorum

MARCH 28, 2022

The company’s current platform encompasses more than two million pages of health content with 20 million unique visitors per month, a telehealth service that has carried out 4.5 million consultations to date and a network of more than 1,500 doctors.

Doctors 52

Doctors Doctor Marketing Pharmacy 52

FDA Law Blog

APRIL 19, 2023

x 11-inch paper, and with hyperlinks to references and numbered pages. label comprehension studies, self-selection studies, actual use studies, and human factors studies), should be included in Module 5 even if they are not clinical studies.

Containment 59

Containment Drugs Cosmetics Marketing 59

pharmaphorum

SEPTEMBER 28, 2022

The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot. The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. .

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Radiology Regulation Engineer Production 132

The Pharma Data

MAY 13, 2021

Activate your 2-week test drive of my Qigong Secrets Home Study Course today and I’ll gift you the mp3 recording a talk I gave recently called: The 7 Secrets Of High Level Qigong and you can access it as soon as you join us. To activate your 2-week trial membership please click once on the button below. Activate Your 2-Week Trial Now.

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Production Trials Branding Vaccination 52

Triage Cancer

SEPTEMBER 24, 2020

Medicare is the federal health insurance program in the United States that provides coverage to individuals who are 65 and older and eligible for Social Security retirement benefits; anyone who has been receiving Social Security Disability Insurance (SSDI) for 2 years; or anyone who has ESRD or ALS.

Drugs 52

Drugs 52

Eye on FDA

JULY 8, 2020

The reason for the lack of time between publication of the notice and holding the actual meeting was stated to be unspecified “technical problems” The agency sates that it will make the background materials available no later than 2 business days prior to the meeting. Hopefully no technical problems there.

Drugs 52

Drugs Production 52

Intouch Solutions

JANUARY 21, 2022

As we moved into year 2, the stream of COVID updates from HR slowed a bit … this was becoming old hat, after all, and by March 2021, employees were told they’d be given the opportunity to select their workplace preferences.

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HR Vaccination Vaccine 98

FDA Law Blog

JUNE 8, 2022

As discussed further below, Althera chose to mess with both the A, B, C’s and the 1, 2, 3’s and got the untitled letter. 1, 2, 3, Or, Don’t Make Up the Numbers. Untitled Letter at 2). ROSZET is indicated to reduce cholesterol in certain groups. Let’s take these in reverse order, as FDA did.

Packaging 52

Packaging Packaging Production Marketing 52

pharmaphorum

MARCH 9, 2021

1 Every year, 19,500 people are diagnosed with lymphoma 2 – a cancer affecting a certain type of white blood cell within the immune system – and can be classed as either slow or fast growing. 2018, page 3. 2012, page 4. Thomas, Samuel Hamerlijnck, Cambridge University Press, 2021, page 1. Lymphoma Action. Wale, Janet L.

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Gene Therapy Development Medicine Clinical Trials 52

Camargo

NOVEMBER 11, 2020

Originally approved for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void, the product has since been discontinued. At 58 pages, almost half of which is a dissent, the case may not be on everyone’s reading list, but it has at least the potential to be an issue for ANDA applicants.

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Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

JULY 10, 2023

According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022. But that is only the beginning. However, the reality is usually different. 510(k) Time to MDUFA IV Decision.

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Packaging Packaging Engineer Cosmetics 75

Pharma Marketing Network

SEPTEMBER 22, 2022

Users that become tired and annoyed by seeing intrusive ads simply begin to ignore them, or worse, completely leave a page. As you begin the creative process of your digital advertising strategy, be sure to keep an eye out for these 4 native advertising trends to ensure successful campaigns. Fight Ad Fatigue with Native.

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Branding Marketing 52

The Pharma Data

JANUARY 4, 2021

All corporate information on Poxel, including financial statements, press releases and corporate presentations, is available on the Investors page of the Company’s website. PXL065 (deuterium-stabilized R-pioglitazone), a MPC inhibitor, is in a streamlined Phase 2 trial for the treatment of NASH. Event.

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Trials Drugs Development Clinical Trials 52

XTalks

SEPTEMBER 11, 2020

Especially in multi-cause conditions, such as type 2 diabetes, treatments must be tailored to patients’ specific risk factors. 2. Lack of healthcare literacy. When trial populations don’t match the broader patient base, the treatments they produce aren’t as effective. Nearly all diseases have a genetic component.

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Clinical Trials Clinical Trials Trials Drugs 98

Pharmaceutical Technology

OCTOBER 17, 2022

Despite economic headwinds – high energy costs are driving inflation, a serious concern for firms’ balance sheets – the UK’s Finance and Leasing Association (FLA) reports asset finance new business grew 2% year-on-year in July 2022. Finance to SMEs increased by 13% over the same period.

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Production Marketing Development 130

Camargo

FEBRUARY 16, 2021

Part 1 offered an overview and side-by-side comparison of the three designations, and now in Part 2, we give a detailed explanation of ODD for rare disease drug sponsors. Subscribe to our mailing list at the bottom of this page to be notified when Parts 3 and 4 are published.

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