FDA Law Blog

SEPTEMBER 19, 2023

Orange Book” and thus, the Policy Statement serves “to put market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.”

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FDA Law Blog

NOVEMBER 9, 2021

The biggest drawback of an eCopy, in our opinion, is the need for physical delivery to the Agency, versus being able to electronically deliver the files. Section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. FD&C Act Section 745(A)(b)(3)(A).

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XTalks

APRIL 10, 2023

For example, in my opinion, telemedicine can be useful in survivorship care where people are generally well and care is focused on surveillance, management of late or long-term side effects, and preventive health. So telemedicine is an accessory to, not a replacement for, in-person care in my opinion.

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Intouch Solutions

DECEMBER 10, 2021

In your opinion, what differentiates Intouch? If you’d like to join a company that former employees come back to – visit our Careers section to learn more about us and check out our many open listings. The opportunities available, plus support and working with a team I had a great experience with.

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FDA Law Blog

DECEMBER 7, 2023

FTC Supreme Court decision stripping FTC of its ability to obtain restitution or disgorgement under Section 13(b) of the Federal Trade Commission Act. She also hinted that such notices may become more common following the 2021 AMG v.

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FDA Law Blog

JULY 7, 2021

Senior Circuit Judge Sentelle, who drafted the opinion, found determinative the statutory restriction prohibiting FDA from interfering in the practice of medicine: When Congress has spoken in a statute, we assume that it says what it means and that the statute means what it says.

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Camargo

OCTOBER 8, 2020

Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and patient population, Commercial strategy, and much more. Camargo provided support by planning the key sections of the TPP to align sponsor goals, patient needs, and product labeling.

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FDA Law Blog

JUNE 13, 2023

This is so even though elsewhere on the webpage the risk information was presented in the “INDICATION AND IMPORTANT SAFETY INFORMATION” section. But the presentation did not mitigate the misleading effect of the “Monitoring and side effects” presentation because the boxed warnings were buried in the middle of a consolidated risk section.

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FDA Law Blog

SEPTEMBER 28, 2023

333(a)(2): “[I]f any person commits such a violation after a conviction of him [of a prohibited act listed in section 331] has become final, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.” But the court’s opinion is not so limited. See FDC Act § 303(a)(2), 21 U.S.C. §

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XTalks

MAY 11, 2023

Maintain neutrality and impartiality, interpreting everything that is spoken, without adding any personal opinions or biases. This can include cutting out sections that are not relevant, adding transitions and color correction. Once your webinar is posted, it will appear in the on-demand sections of xtalks.com.

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Pfizer

SEPTEMBER 27, 2022

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com.

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FDA Law Blog

AUGUST 4, 2022

On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis.

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pharmaphorum

JANUARY 13, 2023

If you’ll forgive a slightly US-centric section, a lot of breath this week was spent griping about the US legislative branch. There can be opinions about the decision, but there was nothing about the report that changed the data.” Ups and downs of government – IRA. Conclusion.

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Pfizer

JANUARY 27, 2023

This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

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The Pharma Data

SEPTEMBER 14, 2020

And John Sartain says mental-health services had failed to act when he asked for his son to be sectioned. “I just find that hard to believe that, you know, after being sectioned twice.” “She didn’t ask to see him or anything, just my opinion of it,” John said. “It was absolutely ridiculous.

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Pfizer

FEBRUARY 1, 2023

The “As We Age” section of the site includes resources, education, and encouragement for older people with cancer and their caregivers, who often face mental health struggles and other life stresses beyond cancer itself.

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Imperical Blog

AUGUST 24, 2021

Good or bad, it’s normal for each of us to have opinions on how we would prefer to word a statement. For example, there may be a mistake in a visit schedule or a section that only applies to a few countries. Usually, we just feel annoyed at how inconsiderate, unprofessional, or ignorant the email’s author is.

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The Pharma Data

MARCH 8, 2022

Sanofi’s ESG profile was awarded 80 points for its solid fundamentals, completed with an additional strong preparedness opinion of 6 points awarded for its ‘ excellent awareness of risks and opportunities ’ and its capacity to ‘ anticipate and adapt to a variety of long-term plausible disruptions ’.

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Pfizer

OCTOBER 18, 2022

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Pfizer and Sangamo Therapeutics Announce Phase 3 Trial of Investigational Gene Therapy for Hemophilia A Has Re-Opened Recruitment. Medicines, Research. 09.16.2022.

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The Pharma Data

OCTOBER 21, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) recently issued a positive opinion recommending marketing authorisation for long-acting cabotegravir and rilpivirine in both injectable and tablet formulations. Such factors include, but are not limited to, those described under Item 3.D

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pharmaphorum

FEBRUARY 24, 2022

As COVID clearly demonstrated, no one section of the healthcare community – whether that’s clinicians, advocacy groups, or industry – can solve a wholescale public health emergency alone. It has to be driven by a coalition of industry actors, the third sector, clinical bodies and key opinion leaders together with policymakers. “By

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report.

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pharmaphorum

MARCH 15, 2022

It was only after surveys conducted in Q4 2020 and throughout 2021 that significant shifts in doctors’ opinions of virtual events were revealed. Equally, commercial partners such as the pharmaceutical industry will be confronted with complex engagement optimisation options where benefits and costs are uncertain (see next section).

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The Pharma Data

OCTOBER 20, 2020

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Moleculin Biotech, Inc.

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FDA Law Blog

AUGUST 10, 2022

Essentially, the lawsuit asks, does FDA have the authority to compel patent certifications where a section viii statement has been filed? 355(b)(2) calls for certification based on “the opinion of the applicant and to the best of his knowledge.” Textually, it makes sense. After all, 21 U.S.C. §

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The Pharma Data

MARCH 17, 2021

Organon will register its common stock under Section 12 of the Securities Exchange Act of 1934 (the “Exchange Act”). Completion of the transaction is subject to a number of conditions, including effectiveness of the registration statement filed with the SEC, receipt of an opinion from tax counsel and other customary conditions.

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WCG Clinical

JULY 17, 2023

Uncharted Territory for Patients The WCG Avoca survey revealed that 75% of patient respondents (who represent a cross section of the US population), have no direct relationship to a trial. Looking at these two surveys together yields a wealth of insights. So, what prevents someone from participating in a clinical trial?

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The Pharma Data

JANUARY 7, 2021

Following the completion of the presentation, a full audio recording will be available in the News section of the Rakuten Medical, Inc website at www.rakuten-med.com and will be archived in this location for 30 days. A live audio webcast of the presentation can be accessed by following this link. About Rakuten Medical, Inc.

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pharmaphorum

AUGUST 25, 2020

It’s going to appear more modern, it’s going to be easier to use and it’s going to be more accessible – for example through the use of colour-coded sections. We carried out opinion research on the Code in 2018, and found that the interviewees associated positive changes in industry practice with developments in the Code.

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Pfizer

JANUARY 27, 2023

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent (..)

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The Pharma Data

APRIL 26, 2021

Reference is made to Sections 6.11(a) a) ( Intentions following the Offer being declared unconditional ) and Section 6.11(b) Reference is made to Section 6.11(c) In consultation with Euronext, it has been decided that the last day of trading of the Shares will be on 24 May 2021. c) ( Buy-Out ) of the Offer Memorandum.

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The Pharma Data

APRIL 28, 2021

Reference is made to Section 5.12 ( Post-Closing Acceptance Period ) of the Offer Memorandum. Reference is made to section 6.11(c) Reference is made to Sections 6.11(a) a) ( Intentions following the Offer being declared unconditional ) and Section 6.11(b) c) ( Buy-Out ) of the Offer Memorandum.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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The Pharma Data

MARCH 22, 2021

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19. 360bbb3(b)(1), unless the declaration is terminated or authorisation revoked sooner.

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The Pharma Data

MAY 16, 2021

Section Three: There?s ClickBank’s role as retailer does not constitute an endorsement, approval or review of these products or any claim, statement or opinion used in promotion of these products. Internal Jogging that Exercises the Body . Song and Dance ? Talking and Walking With Parkinson?s Your Journal ? Your Second Friend .

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The Pharma Data

NOVEMBER 4, 2020

The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

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The Pharma Data

NOVEMBER 22, 2020

Cytokinetics has received positive feedback from key heart failure opinion leaders on the primary results, with particular interest in the potential role of omecamtiv mecarbil in the treatment of advanced heart failure patients who remain at risk for hospitalization despite being treated with standard of care regimens.

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