2022, FDA Approval, Pharmaceuticals and Pharmacy

Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

APRIL 14, 2023

Carolyn R Bertozzi, PhD – Outstanding Achievement in Chemistry in Cancer Research Bertozzi is the Baker Family Director of Sarafan ChEM-H, the Anne T and Robert M Bass Professor in the School of Humanities and Sciences, Professor of Chemistry and, by courtesy, of Chemical and Systems Biology and of Radiology at Stanford University.

Clinical Trials

Clinical Trials Research Science Clinical Research

Article FDA Thank You Addressing benzene contamination, FDA issues guidance for reformulating products containing certain carbomers

Agency IQ

JANUARY 4, 2024

To help control impurities, the FDA requires all starting materials used in drug manufacturing and final pharmaceutical products to be evaluated for “identity, strength, quality and purity.” The company submitted four separate citizen petitions to the FDA from March 2021 through October 2022 regarding benzene impurities.

FDA

FDA Production Laboratories FDA Approval

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

Science

Science FDA Packaging Production

The ACA Contraceptive Mandate (Part 2)

FDA Law Blog: Biosimilars

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

FDA Approval

FDA Approval FDA Production Pharmacy

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The December calendar is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. November is packed with regulatory and industry meetings.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

FDA’s is generally consistent from edition to edition , will each edition consisting primarily of holdovers from previous editions. The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Read our analysis of that rule here and here. ]

Regulations

Regulations FDA Science Production

Economic Theory Explains Big Pharma Scare Tactics on Importation

Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. pharmacies and personal imports from India can be safe as well.

Pharmacy

Pharmacy International Government FDA Approval

Another RICOdiculous Decision

Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , 2022) (many other cases recognize this problem with class actions). 3d 1243 (9th Cir.

Testimonials

Testimonials Pharmacy FDA Doctors

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). 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. 4th 851 (6th Cir. denied , 144 S. 4th 696 (3d. Preemption.

Testimonials

Testimonials FDA Drugs Vaccine

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA

FDA FDA Approval Testimonials Vaccine

Minnesota Court Holds that Dispute with Compounder is Preempted

Drug & Device Law

JUNE 29, 2022

We are always delighted to find a case that bars a claim based on FDA preemption, but Nexus Pharms., LLC , 2022 Minn. May 24, 2022), is unusual. Rather, a pharmaceutical company sued a compounder for fraudulently stealing business from it. It was not FDA approved. IntegraDose Compounding Servs.,

FDA Approval

FDA Approval Regulations Pharmacy FDA

FDA’s Rules are FDA’s to Enforce

Drug & Device Law

OCTOBER 10, 2023

2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Similarly, the court in Nexus Pharmaceuticals, Inc.

FDA Approval

FDA Approval FDA Pharmacy Regulations

Drug Discovery Digest

Who are the AACR Scientific Achievement Award winners?

Article FDA Thank You Addressing benzene contamination, FDA issues guidance for reformulating products containing certain carbomers

Trending Sources

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

The ACA Contraceptive Mandate (Part 2)

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Economic Theory Explains Big Pharma Scare Tactics on Importation

Another RICOdiculous Decision

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

The FDA and Feasible Alternative Designs

Minnesota Court Holds that Dispute with Compounder is Preempted

FDA’s Rules are FDA’s to Enforce

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