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.,

Production 57

Production Cosmetics Manufacturing Licensing 57

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.

Production 57

Production Marketing Drugs Licensing 57

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].

Radiology 52

Radiology Cosmetics Production Licensing 52

FDA Law Blog

AUGUST 17, 2022

Where a consumer spends additional money to receive an OTC hearing aid from a licensed professional, the consumer protections required to be provided by the licensed professional apply; otherwise, those consumer protections may not, as state consumer protections typically are required only of licensees.

Licensing 40

Licensing Licensing Regulation Marketing 40

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

XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

Production 58

Production Insulin Branding Generic Drugs 58

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

FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

Production 57

Production Drugs FDA Approval Compliance 57

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

Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3, A: For FDA 1572 is a Statement of Investigator under US Regulations/Laws. Q: What is the definition of a drug?

Packaging 52

Packaging Packaging Drugs Containment 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

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 67

Drugs FDA Approval Containment Cosmetics 67

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

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 ).

Containment 52

Containment Production Cosmetics Development 52

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.

Regulation 52

Regulation Licensing Licensing Sales 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 Vaccination Vaccine In-Vitro 99

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

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.

Botox 52

Botox Production Sales Cosmetics 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

FDA Law Blog

MAY 21, 2024

because it was not the subject of an approved new drug application (“NDA”) nor an abbreviated new drug application (“ANDA”) under the Federal Food, Drug, and Cosmetic Act. 802(16)) and regulated by 21 C.F.R. d)(23) and marijuana extracts (drug code 7350) regulated by 21 C.F.R. Basis at 63; NPRM at 44,617. at 44,620, 44,622.

Drugs 67

Drugs Regulation Licensing Licensing 67

Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.

Regulation 52

Regulation Drugs Production Medicine 52

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).

Marketing 57

Marketing Production FDA Approval Generic Drugs 57

Pharmacy Checkers

OCTOBER 2, 2020

That is pursuant to Section 804 of the Food, Drug and Cosmetic Act. Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. This authority is granted by Section 804(J2) of the Food, Drug and Cosmetic Act.

Pharmacy 54

Pharmacy Drugs FDA Approval Cosmetics 54

XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. 2) Botox Therapeutic/Cosmetic Botox, or botulinum neurotoxin, is a neurotoxic protein produced by the Clostridium botulinum bacteria. in January 2023, according to the manufacturer.

Sales 93

Sales Manufacturing FDA Approval Life Science 93

Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. J(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation. Importation from Canada is legal under this section of U.S.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

FDA Law Blog

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. By Faraz Siddiqui & Alan M.

FDA Approval 57

FDA Approval Drugs Manufacturing Compliance 57

Pharmacy Checkers

AUGUST 2, 2019

The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act. But such drugs sold from licensed pharmacies are actually approved drugs in the countries where they are dispensed. Trump’s drug importation plan includes two channels of importation.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. J)(2) Waiver authority. for drug safety.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41