XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

Filler 92

Filler FDA Approval Dermatology Production 92

Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

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Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a)(8). Section II at 2.

Drugs 52

Drugs Production Manufacturing Licensing 52

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. It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. and OPKO Ireland Ltd.

Marketing 59

Marketing Production FDA Approval Cosmetics 59

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

Production 59

Production Drugs FDA Approval Compliance 59

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Advarra

JULY 19, 2022

Q: If an emergency use authorization (EUA) is granted, once there is an approved treatment, does that mean that the EUA is no longer valid? If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Can you ship a drug from another country to the U.S.

Packaging 52

Packaging Packaging Drugs Containment 52

FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The drug’s history and current pattern of abuse.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. “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.

Trials 52

Trials Development Dermatology Clinical Trials 52

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

MAY 21, 2024

The Scope, Duration, and Significance of Abuse HHS’ evaluation of epidemiological databases related to medical outcomes from drug abuse placed marijuana in a lower position than alcohol, heroin, and cocaine. is extensive but its use prevalence is less than for alcohol but “significantly more” than any other controlled substances. Basis at 62.

Drugs 69

Drugs Regulation Licensing Licensing 69

FDA Law Blog

SEPTEMBER 5, 2023

Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; Media outlets report, and HHS and Drug Enforcement Administration (“DEA”) officials confirm, that HHS has recommended rescheduling cannabis from schedule I to schedule III. 21 U.S.C. §

Drugs 111

Drugs Cosmetics FDA Approval Licensing 111

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. But the state still needs to pull together several stakeholders and expend additional effort before it can import any drugs.

FDA Approval 59

FDA Approval Drugs Manufacturing Compliance 59