Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). ViXome is an acellular product derived from amniotic fluid. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects.

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XTalks

MARCH 7, 2024

Earlier this week, the US Food and Drug Administration (FDA) took a significant step forward in regulating dietary supplements. The FDA’s decision to finalize these sections responds to feedback received on the draft and demonstrates the agency’s commitment to clarity and usability for industry stakeholders.

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JAMA Internal Medicine

FEBRUARY 14, 2021

This cross-sectional study analyzes the US Food and Drug Administration’s reasons for issuing refuse-to-file letters and assesses public transparency of refuse-to-file letters and their contents.

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JAMA Internal Medicine

NOVEMBER 9, 2020

This cross-sectional study evaluates all of the novel vaccines approved by the US Food and Drug Administration over the last decade.

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FDA Law Blog

AUGUST 10, 2023

Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA). Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012.

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FDA Law Blog

JANUARY 22, 2023

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023 , Pub. FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. 117-328 (2022). has prepared a detailed Summary and Analysis of FDORA.

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FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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XTalks

DECEMBER 7, 2023

On November 30, the US Food and Drug Administration (FDA) unveiled new resources and Frequently Asked Questions (FAQs) to further educate stakeholders about the Food Traceability Rule under FSMA 204. The rule, a key element of the FDA’s New Era of Smarter Food Safety Blueprint, implements Section 204(d) of the FDA FSMA.

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CTTI (Clinical Trials Transformation Initiative)

JANUARY 16, 2024

Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S.

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration.

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Cloudbyz

JULY 20, 2022

The US Food and Drug Administration has recently issued a final guidance for sponsors and applicants who receive an exemption or a waiver from providing regulatory submissions in electronic common technical document (eCTD) format. Issue Date: 24Jun2022.

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Pharmacy Checkers

DECEMBER 18, 2020

In late September, Secretary Azar, in a final rule , certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. Section 804 clearly distinguishes between wholesale (“commercial”) importation (subsections b-h) and personal importation (subsection J).

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The matter involves a “decades old skirmish” dating back to the late 1990s, (and previously blogged about here and here ) when Congress passed the Food and Drug Administration Modernization Act (“FDAMA”), which created Section 503A.

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Rethinking Clinical Trials

SEPTEMBER 21, 2023

Behavioral nudges may increase healthy food purchasing by “nudging” consumers to purchase healthier options by providing discounts or lower-cost options. These findings suggest that the expansion of nutrition incentives to online settings is a potentially promising strategy to promote equitable access to food.

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XTalks

NOVEMBER 24, 2022

Earlier this week, the US Food and Drug Administration (FDA) sent out warning letters to five companies illegally selling CBD-infused food and beverage products. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Currently, the use of CBD in food and beverage products is an unapproved food additive in the US.

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Drug Discovery World

NOVEMBER 30, 2023

The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients.

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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.” Similar requirements would apply to BLA sponsors.

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XTalks

AUGUST 25, 2022

BetterBrand, the startup behind the low-carb, high-protein Better Bagel , announced its global partnership with Whole Foods Market. One year after its online debut, BetterBrand’s Better Bagel hit the frozen shelves of over 500 Whole Foods Market locations, bringing its “Grain-Changing” technology to retail. . Million in Funding.

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XTalks

NOVEMBER 8, 2023

Food delivery startup Wonder Group has received a substantial financial boost from Nestlé, underscoring the company’s initiative to revolutionize the culinary landscape with state-of-the-art kitchen technology and pre-prepared ingredients catered to businesses like hotels, hospitals and sports arenas. billion in 2016.

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CTTI (Clinical Trials Transformation Initiative)

DECEMBER 12, 2023

Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held November 29 and 30, is  now available.  Day 1 of the virtual public workshop opened with welcoming remarks from Karen A. A recording for the virtual public workshop to enhance clinical study diversity convened by the U.S.

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FDA Law Blog

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. sections 331(a) and 352.(a)(l), The way that matter ended up—after touching all three branches of the U.S.

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XTalks

APRIL 13, 2021

New data from the Plant Based Foods Association (PBFA) and The Good Food Institute (GFI) shows that the retail sales of plant-based foods in the US grew by 27 percent in 2020, bringing its total market value to $7 billion. Why Are Retail Sales of Plant-Based Foods Up? Food safety. Taste and dietary variety.

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CTTI (Clinical Trials Transformation Initiative)

AUGUST 8, 2023

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting on Oct. The free two-day virtual public meeting will be held on Oct. 18 and 19 from 10 a.m. – 1:30 p.m.

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FDA Law Blog

JANUARY 7, 2024

As a result, failure to conduct a PMR would be a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and/or implementing regulations, subject to enforcement action. Under Section 505(o) of the FDCA, FDA may only require a PMR for one of the following reasons: “To assess a known serious risk related to the use of the drug involved.”

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FDA Law Blog

AUGUST 27, 2023

FDA does not intend to take action to enforce the requirements, as described below, until November 27, 2024. More specifically, FDCA Section 582(g)(1)(B) requires that, as of November 27, 2023, the transaction information required to be exchanged include the product identifier (i.e., By Karla L. Guidance at 5.

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BioTech 365

AUGUST 24, 2020

(Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that findings from APPEAL-2 (Allergy to Peanuts ImPacting Emotions And Life-2), the largest cross-sectional, pan-European, qualitative study to evaluate the … Continue reading →

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CTTI (Clinical Trials Transformation Initiative)

OCTOBER 31, 2023

Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held October 18 th and 19 th , is now available.  Day 1 of the virtual public meeting opened with welcoming remarks from Janet Woodcock, FDA’s Principal Deputy Commissioner.

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FDA Law Blog

DECEMBER 8, 2021

Moore — Nothing says “happy holidays” quite like the issuance of Federal Trade Commission (FTC) orders – essentially, subpoenas – to large retailers , wholesalers and suppliers of food, cosmetics, personal care and OTC products, among other things, during the supply chain’s busiest time of the year. Tyson Foods, Inc., Amazon.com, Inc.,

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FDA Law Blog

OCTOBER 26, 2022

Walsh — The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. In the interim, the issue has reared its head again in FDA’s recently issued guidance for industry, titled Refusal of Inspection by a Foreign Food Establishment or Foreign Government.

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Intouch Solutions

JUNE 10, 2022

The afternoons were full of food, drinks, activities, games, prizes, and connecting with coworkers. We unveiled our new brand – EVERSANA INTOUCH – and had celebrations across many of our offices to mark the occasion with some fun and cameraderie! Want to know more about what it’s like to work at EVERSANA INTOUCH?

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Drug Discovery World

DECEMBER 5, 2023

It has been granted approval by the Food and Drug Administration (FDA) to treat patients who have received at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. .

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pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. When in doubt, counsel may be able to assist with an analysis of the applicable regulatory requirements, or developers may request a determination from the FDA directly by submitting a request for information in accordance with Section 513(g) of the FD&C Act (21 U.S.C.

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Cloudbyz

JULY 20, 2022

Issue Date: 24Jun2022 The US Food and Drug Administration has recently issued a final guidance for sponsors and applicants who receive an exemption or a waiver from providing regulatory submissions in electronic common technical document (eCTD) format.

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FDA Law Blog

MAY 8, 2023

The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA). FDORA added section 515C, “Predetermined Change Control Plans for Devices” to the Federal Food, Drug, and Cosmetic (FD&C) Act.

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FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). Section II at 2. However, Section III.B.2(a) See 21 U.S.C. This is a much-needed clarification for industry.

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FDA Law Blog

DECEMBER 21, 2022

Two days after the blog post, FDA updated the Digital Health Policy Navigator to improve access to the tool through the webpage and add examples to the clinical decision support software policy considerations in Step 6. medication reconciliations and test reconciliations); Reminders for preventive care or clinician’s orders; and.

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Drug Discovery World

MARCH 31, 2023

The US Food and Drug Administration (FDA) has granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.

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