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Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance).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. Draft Guidance III.B.2(e)

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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. between 2023 and 2035.

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FDA Law Blog

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI, In other words, it’s a get-what-you-pay-for type situation.

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Pharmacy Checkers

DECEMBER 18, 2020

drug prices, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) may be stepping on its toes in helping to allow more personal drug importation. 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.

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XTalks

FEBRUARY 8, 2021

Crucially, biosimilars manufacturers must also demonstrate that their product’s safety and efficacy profile won’t go down if a patient switches back and forth between the biosimilar and the reference product during the course of treatment. Because most biologics are mixtures of variants, they really can’t be copied exactly.”.

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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 company manufactures and distributes several proprietary retail products and product lines, mainly focused on the Cannabidiol (“CBD”) and Cannabigerol (“CBG”) Edibles market segment.

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Pharma in Brief

JANUARY 10, 2024

The pCPA negotiates with manufacturers on behalf of Canada’s provincial, territorial, and federal governments. The US Food and Drug Administration kicked off 2024 by authorizing the first drug importation program by a US State (Florida) under section 804 of the US Food, Drug, and Cosmetic Act (see here ). pCPA incorporates.

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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. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Q: What is your advice for approaching the regulatory strategy?

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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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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 .

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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.

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Pfizer

NOVEMBER 23, 2022

Europe plays a critical role in the delivery of PAXLOVID to patients across the globe, as the site of four of Pfizer’s key PAXLOVID manufacturing facilities. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries. IMPORTANT SAFETY INFORMATION.

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. every eight weeks for the 90 mg dose, according to the manufacturer. First FDA-approved in July 2017 for plaque psoriasis, the list price for a 30-day supply of Tremfya was stated to be $6,292, according to the manufacturer.

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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]. N= 3,525 total study population. About Allergan Aesthetics.

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XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

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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)(A). 21 U.S.C. § 802(16)(B).

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FDA Law Blog

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. at 53,740, 53,821. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016.

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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(3) is specific to Canada and basically tells the FDA to permit personal importation from licensed pharmacies that require a valid prescription.

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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.

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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. The FDA-approved Daraprim, manufactured by Vyera Pharmaceuticals, costs over $750/pill. The version in the UK, manufactured by GlaxoSmithKline, sells for about $6/pill in that country.

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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.

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Pharmacy Checkers

JULY 28, 2020

Licensed pharmacies in many other countries are safe and charge much lower prices than those in the United States. A handful of states have passed importation legislation to allow state-licensed, wholesale pharmacies to import from Canadian wholesale pharmacies. And they are not prosecuted for doing so. It makes sense.

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