XTalks

JUNE 5, 2023

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. Furthermore, patients should only purchase Ozempic, Wegovy or other medications from licensed healthcare providers or pharmacies.

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XTalks

SEPTEMBER 4, 2020

Nowadays, the word’s meaning is commonly extended to refer to non-food products—such as clothing, cosmetics, and medicine—that are made without animal-derived substances. The word vegan was initially defined as a diet free of animal-based foods (such as meat, dairy products, eggs and honey.)

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Production Cosmetics Licensing Licensing 69

pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Criteria for regulation.

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Development Regulation Cosmetics Life Science 105

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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

pharmaphorum

SEPTEMBER 29, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

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Development Regulation Production Life Science 104

FDA Law Blog

APRIL 25, 2024

While the Federal Food, Drug & Cosmetic Act does not explicitly define “advertisement,” FDA provides several examples in its regulations at 21 CFR § 201.1(l)(1) l)(1) (e.g.,

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Production Cosmetics Manufacturing Licensing 59

Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002.

Filler 40

Filler Cosmetics Production Dermatology 40

Pfizer

DECEMBER 13, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., IMPORTANT SAFETY INFORMATION .

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

APRIL 15, 2022

The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes. director of the FDA’s Center for Devices and Radiological Health. Source link: [link].

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Radiology Cosmetics Production Licensing 52

XTalks

FEBRUARY 8, 2021

When a new biologic drug is in development, innovator biopharmaceutical companies have the burden of establishing the de novo safety and efficacy of the product through analytical testing, nonclinical studies, clinical pharmacology and the phases of clinical trials as established by the 351(a) Biologics License Application (BLA) process.

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Production Insulin Branding Generic Drugs 78

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. That clause excludes those ingredients that were first marketed as drug ingredients.

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Production Marketing Drugs Licensing 59

Roots Analysis

JANUARY 29, 2024

Body Contouring: Body contouring is a cosmetic procedure that aims to redefine, recreate and reshape the body. Hair Removal: It is a cosmetic procedure that uses different types of light to get rid of hair follicles and get rid of unwanted hair on any part of your body. The most popular technique is laser tattoo removal.

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Filler Cosmetics Botox Marketing 40

The Pharma Data

FEBRUARY 5, 2021

” said Dr. Sabrina Fabi , Board Certified Dermatologist and Associate Research Director at Cosmetic Laser Surgery in San Diego. American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. For more information and to find a provider near you, visit [link].

Cosmetics 52

Cosmetics Dermatology Allergies Production 52

XTalks

MAY 22, 2023

According to Allergan Aesthetics, SkinVive is slated for commercial availability within the next six months, exclusively through licensed physicians and practitioners. SkinVive will be the first and only intradermal microdroplet injection of hyaluronic acid available in the US, representing a significant milestone in skincare innovation.

Filler 92

Filler FDA Approval Dermatology In-Vivo 92

Roots Analysis

AUGUST 7, 2023

Partnership Activity Focused on Cell Free Systems Several stakeholders have been forging alliances with other industry / non-industry players in cell free expression market for product development, research and development and technology licensing purposes.

Marketing 52

Marketing Protein In-Vitro Production 52

The Pharma Data

APRIL 1, 2021

2 When designing the SkinMedica ® Neck Correct Cream, it was imperative for our R&D team to address these concerns with a multi-modal approach and develop a product with cutting edge ingredients, a cosmetically elegant texture and clinically-proven performance.” At week 12, on the Décolleté: n=42.

Production 52

Production Protein Cosmetics Licensing 52

Druggist

OCTOBER 25, 2020

Nevertheless, calamine lotion is licensed in the UK for symptomatic relief of skin conditions including itchiness. Both products have the same licensed use: symptomatic relief of mild sunburn and relief from other skin conditions. Liquid antihistamine – chlorphenamine (Piriton syrup) is licensed for this indication.

Production 52

Production Pharmacy Licensing Licensing 52

FDA Law Blog

FEBRUARY 2, 2023

42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA replaces the language in (bb) regarding animal studies with “an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc).”

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Clinical Trials Clinical Trials In-Vivo In-Vitro 64

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). Draft Guidance III.B.2(e)

Drugs 52

Drugs Production Manufacturing Licensing 52

Pfizer

DECEMBER 20, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., IMPORTANT SAFETY INFORMATION.

Drugs 69

Drugs Licensing Licensing Containment 69

FDA Law Blog

AUGUST 17, 2022

Further, FDA explained that state consumer protection laws can continue to be imposed through any licensing requirements that remain for hearing care professionals, meaning that some consumer protection laws may apply to some OTC hearing aids but not others depending on the seller. In other words, it’s a get-what-you-pay-for type situation.

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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. The record results achieved on November 25, 2020 were followed up by another very strong showing on Thanksgiving Day (November 26, 2020).

Life Science 52

Life Science Production Cosmetics Manufacturing 52

Pfizer

AUGUST 15, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., PAXLOVID is not authorized for use for longer than 5 consecutive days.

Drugs 99

Drugs Vaccine Vaccination In-Vitro 99

FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

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Production Sales Drugs Cosmetics 52

FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act.

Drugs 69

Drugs FDA Approval Containment Cosmetics 69

FDA Law Blog

FEBRUARY 29, 2024

156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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Production Drugs FDA Approval Compliance 59

The Pharma Data

FEBRUARY 4, 2021

– Full-Year Global Net Revenues from the Aesthetics Portfolio Were $2.590 Billion; Global Botox Cosmetic Net Revenues Were $1.112 Billion. Global Botox Cosmetic net revenues were $493 million , an increase of 9.1 Botox Cosmetic*. Botox Cosmetic*. – Reports Fourth-Quarter Diluted EPS of $0.01 Imbruvica c.

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Botox Production Sales Cosmetics 52

FDA Law Blog

NOVEMBER 22, 2021

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). Please see our previous blog postings on various software regulatory developments ( here, here, and here ).

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Containment Production Cosmetics Development 52

The Pharma Data

MARCH 4, 2021

“For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. . They lose much more than just hair,” said Lotus Mallbris, M.D.,

Trials 52

Trials Development Dermatology Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

Federal Food, Drug and Cosmetic Act (“FD&C Act”), regarding the regulatory requirements applicable to its robotically assisted surgical device (“RASD”), the Enos Robotic Single Access System. Food & Drug Administration (“FDA”) to its Request for Information in accordance with Section 513(g) of the U.S.

Containment 40

Containment Marketing Development Regulation 40

Pfizer

NOVEMBER 23, 2022

Voluntary Licensing : Signed a voluntary license agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer’s oral treatment to further expand long-term global supply and access. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Licensing 40

Licensing Licensing Drugs Manufacturing 40

Advarra

JULY 19, 2022

To get an approved NDA or Biologics License Application (BLA) you must conduct all phases of clinical studies. Additional information about this stay can be found in the Notice of Stay published in the Federal Register, October 30, 2015 (80 FR 66907). Q: What is the definition of a drug? Then you can submit an application for approval.

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Packaging Packaging Drugs Containment 52

The Pharma Data

APRIL 30, 2021

Global Botox Cosmetic net revenues were $477 million , an increase of 44.7 a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. Botox Cosmetic*.

Botox 40

Botox Production Development Cosmetics 40

Pharmaceutical Technology

APRIL 4, 2023

On April 4, Scorpion Therapeutics announced a collaboration and license agreement with the French dermo-cosmetic and pharmaceutical group Pierre Fabre to codevelop two next-generation epidermal growth factor receptor (EGFR) inhibitors. STX-241 and STX-721, both target EGFR mutations in non-small cell lung cancer (NSCLC).

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Cosmetics Development Licensing Licensing 130

pharmaphorum

FEBRUARY 11, 2022

Privately-held Mayoly Spindler is a specialist in gastroenterology and dermato-cosmetic products that has set itself the target of becoming a top 10 European OTC medicines company in the next 10 years. billion takeover of Clementia Pharma in 2019.

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Sales Pharma Companies Branding Cosmetics 103

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 For additional information, please visit www.crescitatherapeutics.com.

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Licensing Licensing Dermatology Production 40

FDA Law Blog

JUNE 21, 2022

For those unfamiliar with the hearing aid industry, the industry faces regulations on all fronts: FDA regulates the devices while states regulate their distribution and impose conditions of sale via their licensing authority over “hearing health professionals” including audiologists or hearing aid dispensers.

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