FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Drugs Pharmacy Licensing 105

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

FDA Law Blog: Biosimilars

JUNE 2, 2023

Stacking” refers to aggregating discounts provided by a manufacturer to different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. Allergan Sales , which affirmed a lower court decision in a Federal False Claims case involving best price stacking.

Drugs 59

Drugs Regulations Vaccine Government 59

Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Agency IQ

JANUARY 26, 2024

In its 2022 annual report to Congress on drug shortages, the FDA notes that one method of mitigating a shortage – once the agency is aware of the shortage at all – is “reviewing requests for extensions of expiration dating.” What happens when a drug is not stored in its original container or within a licensed facility?

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The latest update, announced this week, is known as the Spring 2023 Unified Agenda. Of those 51, just four are new to the Agenda, having never before been made public.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

FDA 40

FDA Production Licensing Licensing 40

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

Draft published December 2022. Priority B List. CDRH Final 12/29/2023; overdue FDA must issue final guidance no later than one year after the close of the public comment period for the draft guidance.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Drug Target Review

FEBRUARY 11, 2025

2021-2022, this likelihood of approval (LOA) dropped below 6 percent, yet more recently they are returning to 10-11 percent, but still nowhere near what they used to be. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes.

Drug Development 59

Drug Development Bioinformatics Drugs Small Molecule 59

Drug & Device Law

JANUARY 4, 2024

2022) (same result as to other COVID-19 vaccine). Alabama State Board of Pharmacy , 61 F.4th April 13, 2022) (available here ). 2022) (quoting this publication). “The Okuley’s Pharmacy & Home Medical , N.E.3d 247d-6d(b)(8). 25, 2023); Goins v. Saint Elizabeth Medical Center , 640 F. 3d 745, 753 (E.D.

Vaccine 59

Vaccine FDA FDA Approval Production 59

Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. Preemption.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. 2022), the intermediate appellate decision that we discussed here. 2022); Pisano v.

Vaccine 59

Vaccine Pharmacy Hospitals Licensing 59

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. In at least the short term, a popular pain reliever would have to be removed from pharmacies. 3d , 2022 WL 6225596 (S.D.

FDA 59

FDA FDA Approval Testimonials Vaccine 59