Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands.

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Regulation Research Production Cosmetics 97

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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XTalks

SEPTEMBER 28, 2023

This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. Companies use the GRAS designation as a shortcut, introducing thousands of additives — some with known and unknown health risks — into American food products.

Hormones 52

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FDA Law Blog

APRIL 21, 2024

For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

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FDA Law Blog

JULY 7, 2022

Sponsors have been unable to overcome the challenges of switching some widely used prescription drugs to OTC for a very long time and a path to market may be clearing for at least some of these and others. Drugs currently on the market OTC would not be approved with ACNU. This concept of operationalizing (operationalization?)

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Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act. Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).

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FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

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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. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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XTalks

APRIL 26, 2021

The Upcycled Food Association (UFA) recently introduced its certification marker to provide consumers with guidance about the presence of upcycled foods in a wide range of products. The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. Defining Upcycled Foods.

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FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. is filled with a Teva generic product. Using other topical acne products may increase the irritation of your skin when used with Adapalene and Benzoyl Peroxide gel. 2.5%), in the United States. Adapalene and benzoyl peroxide gel 0.3%/2.5%

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Doctors Doctor Medicine Production 52

FDA Law Blog

OCTOBER 17, 2021

nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). The deemed final order establishes the current monograph for OTC sunscreen products. M002) and an Order ID (e.g.,

Containment 52

Containment Drugs Production Cosmetics 52

XTalks

APRIL 14, 2021

This process has been used in the food industry before, such as in cheese production, for example. Synthetic dyes are found in several food products, such as canned peas, candy and cake icing. They are also found in beverages such as sports drinks and beauty products such as mouthwash and shampoo.

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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 About Juyou Bio – Technology Co. Juyou Bio-Technology Co.,

Licensing 40

Licensing Licensing Dermatology Production 40

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 products advance the practice of dentistry and medicine for patients and healthcare professionals. About BIOLASE, Inc.

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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. There is also substantial interest, from major industry players, in the Company’s proprietary Tauri-Gum product line.”. . ABOUT TAURIGA SCIENCES INC. .

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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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). It does not apply to software-related documentation that may be needed to evaluate post market software device issues (e.g.,

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XTalks

JULY 26, 2023

We are primed and ready for our next major leap — the global scale production of Brevel’s protein that will be integrated into healthier, tastier and environmentally-friendly food products in every household.” The first food products containing Brevel’s protein are scheduled to hit the market by 2024.

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Protein Production Cosmetics Marketing 97

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.

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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.

Production 52

Production Sales Drugs Cosmetics 52

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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Regulation Production Cosmetics Sales 45

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.

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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. . billion, about 50% was dedicated to regulating medical products, including prescription drugs. Far from it.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

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. 21 U.S.C. § 802(16)(B). chemotherapy-induced), pain, and post-traumatic stress disorder.

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FDA Approval Drugs Containment Cosmetics 69

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. It contains the antiviral medications nirmatrelvir and ritonavir.

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Sales Manufacturing FDA Approval Life Science 98

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. PAXLOVID is currently authorized for conditional or emergency use in more than 70 countries across the globe. Our Commitment to Access.

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Licensing Licensing Drugs Manufacturing 40

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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Regulation In-Vitro Manufacturing Licensing 81

FDA Law Blog

FEBRUARY 15, 2022

FDA has adopted a tiered meeting framework not unlike the Type A, B and C meeting categories established under the Draft Guidance for meetings with sponsors of PDUFA products (the PDUFA Guidance). By Deborah L. The Monograph Meeting Guidance describes Type X, Y and Z meetings essentially as they are set out in the Goals Letter.

Cosmetics 40

Cosmetics Drugs Development Regulation 40

FDA Law Blog

NOVEMBER 14, 2022

The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product. FDA stresses that the law does not provide exemptions or waivers.

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The Pharma Data

DECEMBER 28, 2020

The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. 1 American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders.

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Pharmacy Checkers

DECEMBER 20, 2019

The proposed rule provides specifics so that states contemplating or already formulating wholesale drug importation programs have a shot at gaining approval for those programs, per Section 804 of the Food, Drug and Cosmetic Act. Drug manufactures may simply not provide Canada with more of its products, knowing they could get more at U.S.

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