FDA Law Blog

JANUARY 12, 2025

FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s. Moreover, it was also interesting to see how FDA discussed the concept of unmet medical need in the limited fashion that it did in this new guidance.

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FDA Law Blog

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

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FDA Law Blog

MAY 6, 2024

The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). Manufacturers are required to design, develop, and provide a “reasonable assurance” that both the cyber device and related systems (e.g., are cybersecure.

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XTalks

SEPTEMBER 28, 2023

Parabens, which are also prevalent in cosmetics, can interfere with the regular operation of human hormonal systems, affecting both male and female reproductive health, development, fertility and birth results. Citrus-flavored beverages are particularly prone to containing BVO. BVO tends to accumulate in the human body.

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FDA Law Blog

APRIL 12, 2022

This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. A key to efficient drug development is transparency.

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XTalks

APRIL 14, 2021

The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments. Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color.

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FDA Law Blog

APRIL 25, 2023

A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”?

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XTalks

APRIL 26, 2021

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. The definition ultimately served as a jumping-off point for the UFA to develop its certification marker and membership. Even before the term was formally defined, upcycled foods had been gaining momentum.

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FDA Law Blog

JULY 4, 2023

After FDA issues a final order under Section 505G of the Food, Drug, and Cosmetic Act, requestors who will be subject to the final order and sponsors of OTC monograph drugs that will be subject to the final order are eligible to request formal dispute resolution.

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FDA Law Blog

OCTOBER 17, 2021

Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). We here at HPM hope that FDA will continue to maintain the webpage Status of OTC Rulemakings which contains easily accessed historical information and links. For each OTC monograph title (e.g.,

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

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The Pharma Data

NOVEMBER 4, 2020

(TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

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XTalks

JANUARY 5, 2024

While weight loss service providers such as Weight Watchers and Noom have begun to offer Zepbound and Wegovy through their telehealth services, pharma companies focus on the development and manufacturing side of things and don’t typically involve themselves in home delivery of drugs or connecting patients, providers and pharmacies.

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FDA Law Blog

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.

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Olympian Clinical Research

MARCH 1, 2024

Although age spots pose no health risk, their appearance can be a significant cosmetic concern for many. Age spots develop when the pigment-producing cells in the skin (melanocytes) become more active with age and prolonged sun exposure. Genetics, hormonal changes, and certain medications can also play a role in developing age spots.

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FDA Law Blog

NOVEMBER 9, 2021

As that program was underway, FDA developed another pilot program for electronic 510(k)s using the electronic submission template and resource (eSTAR). It defines an electronic submission, or eSubmission, as a “submission package produced by an electronic submission template that contains the data of a ‘complete’ submission.”

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Roots Analysis

JULY 28, 2024

While cosmetic procedures can effectively target specific aging concerns like deep wrinkles, sagging skin, and volume loss, they may not comprehensively improve the overall skin quality. Customers complete an online consultation and receive a personalized prescription cream containing active ingredients tailored to their needs.

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The Pharma Data

NOVEMBER 26, 2020

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. for the co-development of a rapid, multiplexed, Novel Coronavirus (COVID-19) test with superior sensitivity and selectivity. . . The Patent, filed with the U.S.P.T.O.

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The Pharma Data

DECEMBER 29, 2020

(“Titan” or the “Company”) (TSX: TMD) (Nasdaq: TMDI) , a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announces that the Company has received a written response from the U.S. About Titan Medical. Titan Medical Inc., Enos is a trademark of Titan Medical Inc.

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FDA Law Blog

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. PFI has noted that it is not feasible to develop and label products for an individual state.

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The Pharma Data

DECEMBER 4, 2021

Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes. NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. About Teva.

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FDA Law Blog

FEBRUARY 15, 2022

OTC monograph order requests or OMORs), other matters relevant to the regulation of nonprescription drugs, and the development of new nonprescription drugs under section 505G. Specifically, Type X meetings are limited to: A meeting that is necessary for an otherwise stalled OTC monograph order development program to proceed.

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FDA Law Blog

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement. The new § 820.10 Revised § 820.3 FDA further retained some definitions in the QSMR.

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FDA Law Blog

JULY 7, 2022

The first was to develop labeling beyond the DFL and the second was to propose “additional conditions that a consumer must fulfill” with the examples self-selection tests utilizing a mobile app or a requirement for the consumer to affirm they have watched a video or read text about use of the drug.

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Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. and are defined as: Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.

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The Pharma Data

JANUARY 31, 2021

BIOLASE is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE’s principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. About BIOLASE, Inc.

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The Pharma Data

DECEMBER 28, 2020

About Alkermes plc Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. 31, 2019, the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S.

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The Pharma Data

NOVEMBER 4, 2020

Key findings of the research showed that patients with alopecia areata suffer significantly increased burden of illness, including a negative impact on many aspects of daily life, extending considerably beyond the cosmetic concerns of hair loss. Research and development expenses were $16.3 CTP-692 Phase 2 Enrollment Complete.

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 – Nearly 15% of talc-based cosmetic products analyzed in a recent study contained asbestos. Environmental Working Group (EWG) — an American advocacy nonprofit that commissioned the tests and did the analysis — said methods used by the cosmetics industry to screen talc supplies are inadequate. MONDAY, Nov.

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Roots Analysis

AUGUST 8, 2023

The hydrophobic portion contains two fatty acid chains with 10-24 carbon atoms, while the hydrophilic part primarily consists of phosphoric acid linked to a water-soluble molecule. Other applications of liposomes include the encapsulation of food and cosmetic materials, along with routine chemical analysis.

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The Pharma Data

MARCH 7, 2022

Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine. “It

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Roots Analysis

SEPTEMBER 9, 2024

In addition, other industries, such as agriculture, cosmetics, food, environmental sciences, biomedical research and enzyme synthesis industry, are also benefiting from the protein expression process. However, this is still a nascent protein expression technology and is relatively less developed than other host systems.

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FDA Law Blog

NOVEMBER 22, 2021

Please see our previous blog postings on various software regulatory developments ( here, here, and here ). This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17 Act). corrections and removals).

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device.

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FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct? and OPKO Ireland Ltd.

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FDA Law Blog

JANUARY 23, 2023

More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

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