FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. RE 44,638 and with respect to each NDA approval, See FDA Docket Nos.

FDA Approval 59

FDA Approval FDA Production Therapies 59

Drug Discovery World

MAY 11, 2023

This high level of quality control is also demanded and regulated by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which consider HCPs a critical quality attribute (CQA). 2015): 1727-1737. ” Biotechnology and bioengineering 112.9 Collins, Ben C., 2017): 1-12.

Production 130

Production Vaccine Immune Response Therapies 130

The Pharma Data

FEBRUARY 8, 2021

The recruitment period for the study spanned from December 2015 to July 2017. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. ERLEADA ® received U.S. 2 To date, more than 10,000 patients worldwide have been treated with ERLEADA ®.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

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.

FDA 40

FDA Science Regulations Production 40

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 40

FDA Science Regulations Production 40

The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. 3 In August 2019 , RINVOQ received U.S. Available at: [link]. Available at: [link].

Treatment 40

Treatment Disease Therapies Clinical Trials 40

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The FDA sought input on these criteria from the PCAC in 2015 and again in 2016.

FDA 40

FDA Pharmacy Production Drugs 40

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products. In most states, this defers to the USP recommendation.

Science 40

Science FDA Packaging Production 40

The Pharma Data

AUGUST 17, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. CTLA-4 is a negative regulator of T-cell activity. About Yervoy.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

The Pharma Data

SEPTEMBER 8, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. CTLA-4 is a negative regulator of T-cell activity. About Yervoy.

Research 52

Research Immune Response Treatment Trials 52

The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

Production 52

Production International Clinical Trials Small Molecule 52

The Pharma Data

JANUARY 29, 2021

Janssen has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. COV2-S (SARS-CoV-2 vaccine) FDA Approval History. Department of Health and Human Services (HHS). i] [link] [ii] The B.1.351 Posted: January 2021.

Vaccine 40

Vaccine Trials Pharmaceutical Companies Immune Response 40

Drug & Device Law

DECEMBER 29, 2023

The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. Express and implied preemption operate independently ( see Buckman ), thus the express Prop 65 saving clause was irrelevant.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

Drug & Device Law

JANUARY 9, 2023

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. 201.326(a)(1).

Regulations 59

Regulations Nurses FDA FDA Approval 59

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

SEPTEMBER 9, 2022

After opportunity for notice and comment, the FDA promulgated literally hundreds of regulations classifying device types. Despite that classification, the statute allowed it to be cleared even before approval based on its equivalence to a device on the market in 1976, when MDA device regulation began. See 21 C.F.R.

FDA 59

FDA Regulations Marketing FDA Approval 59

Drug & Device Law

SEPTEMBER 12, 2022

The plaintiffs in Pfaff , who opted out of the settlement, had originally brought suit in California federal court back in 2015. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. 12 (citation and quotation marks omitted).

FDA 59

FDA FDA Approval Regulations International 59

Drug & Device Law

JANUARY 13, 2023

The motions were teed up as to the claims of five plaintiffs whose use occurred solely during a period when it was uncontested that the generics had FDA-approved labeling that matched that of the branded drug.

Drugs 59

Drugs Regulations FDA FDA Approval 59

Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. We were hardly alone. & Man’l Epid’y. Studnicki J, Harrison D.J.,

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). 2015)), Booker v. 379r(a)(1). 379r(a)(1).

Drugs 105

Drugs Regulations Production FDA Approval 105

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. .

Production 52

Production FDA Approval Compliance FDA 52

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 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

AUGUST 31, 2023

b)(2) not to make such a change without first obtaining FDA approval.” As construed by the court, the complaint alleged that the biologic approved by the FDA is defective as a matter of state law. 2015), while as we discussed here , the Seventh Circuit reached the contrary conclusion in Kaiser v. 3d 281 (6th Cir.

FDA Approval 59

FDA Approval FDA Production Pharmaceuticals 59

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

FDA Approval 64

FDA Approval FDA Regulations Production 64

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. On occasion, states have attempted to prohibit sale and/or use of non-abortion-related FDA-approved products, but with one exception, these efforts have not resulted in litigation.

FDA Approval 116

FDA Approval FDA Regulations Drugs 116