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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). That was the case in the PTO’s April 3, 1995 decision denying a PTE as to U.S.

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

FDA Law Blog

AUGUST 17, 2022

Thus, only self-fitting hearing aids need to be cleared by FDA prior to marketing; regular OTC hearing aids—ones that are customizable based on user preference—do not, and consumers must rely on FDA postmarket enforcement activities to ensure safety and effectiveness of OTC hearing aids (more on that later).

Licensing 40

Licensing Licensing Regulation Marketing 40

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Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). Draft Guidance III.B.2(e) More specifically, the prohibition includes when a “third party (e.g.,

Drugs 52

Drugs Production Manufacturing Licensing 52

The Pharma Data

APRIL 1, 2021

. “The neck and décolleté area are extensions of the face but require a totally different treatment plan due to the unique biology of the neck skin,” says Colleen McKenna , Vice President of Facial Aesthetics & SkinMedica ® Marketing, Allergan Aesthetics. The skin of the neck is also thinner, similar to the skin on eyelids.

Production 52

Production Cosmetics Protein Licensing 52

XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

Production 78

Production Insulin Branding Generic Drugs 78

Pharma in Brief

JANUARY 10, 2024

Changes in Canada’s pricing and market access regimes This year saw major developments in the drug price and reimbursement space, including at the Patented Medicine Prices Review Board ( PMPRB ), the pan-Canadian Pharmaceutical Alliance ( pCPA ), and the Canadian Agency for Drugs and Technologies in Health ( CADTH ).

Regulation 52

Regulation Drugs Production Medicine 52

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.

Life Science 52

Life Science Production Cosmetics Manufacturing 52

FDA Law Blog

FEBRUARY 29, 2024

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. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application.

Production 59

Production Drugs FDA Approval Compliance 59

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.,

Containment 52

Containment Production Cosmetics Development 52

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

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

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. License and research and development revenue. .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Dermatology 52

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

The Pharma Data

FEBRUARY 5, 2021

CoolSculpting ® has been an industry-leader, creating the market for non-invasive fat reduction over 10 years ago. ” said Dr. Sabrina Fabi , Board Certified Dermatologist and Associate Research Director at Cosmetic Laser Surgery in San Diego. “The number one aesthetic concern for consumers is excess body fat 1.

Cosmetics 52

Cosmetics Dermatology Allergies Production 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

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

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. The FDA interprets “pattern” to refer to multiple, sequential, or repeated measurements of a signal or from a signal acquisition system. Criterion 2.

Development 96

Development Regulation Cosmetics Life Science 96

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*. – Reports Fourth-Quarter Diluted EPS of $0.01 percent on a reported basis, or 45.0

Botox 52

Botox Production Sales 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.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69

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. market clearance,” said David McNally, President and Chief Executive Officer of Titan. “At Enos is a trademark of Titan Medical Inc.

Containment 40

Containment Marketing Development Cosmetics 40

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. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmacy Checkers

SEPTEMBER 25, 2020

As a quick reminder, pursuant to Section 804 of the Food, Drug and Cosmetic Act, the FDA issued a proposed new rule to allow wholesale imports of lower-cost drugs from Canada, subject to many conditions and excluding expensive biologics. Find it here: Section 804 Final Rule. It’s 179 pages so I haven’t had time to read it all yet.

Drugs 80

Drugs Pharmacy Cosmetics Licensing 80

Pharmacy Checkers

AUGUST 2, 2019

Until this week, it was known that Trump had instructed Secretary Azar to work with Republican Governor Ron DeSantis of Florida to help implement its new law to permit wholesale drug importation from Canada for public payers, which also includes importation from other countries for the private market. Now, there is real movement.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69