Agency IQ

NOVEMBER 20, 2023

Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.) If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.

Production 40

Production Packaging Hospitals Regulations 40

Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

Regulations 40

Regulations International Pharmaceuticals Production 40

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

Regulations 40

Regulations Production Packaging FDA 40

Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

Regulations 40

Regulations Marketing Production Vaccine 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

Agency IQ

DECEMBER 15, 2023

In 2020, the European Commission adopted the Pharmaceutical Strategy for Europe , noting that medicines shortages “have been a serious concern in the EU for several years.” The Pharmaceutical Strategy document notes that the Covid-19 pandemic compounded medicines shortages that had already impacted patient health and the E.U.

Regulations 40

Regulations Pharmaceuticals Treatment Vaccine 40

The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. CHATHAM, N.J., Holding Corp. 175:1091-1101 (1992) 2 Karpusas, M et al.,

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

Codon

DECEMBER 12, 2024

A drug called thalidomide, initially made by a West German pharmaceutical company called Chemie Grünenthal, was manufactured and given to patients as a mixture containing both enantiomers. In 2001, in an outbreak that had nothing to do with a lab leak, foot-and-mouth disease in the U.K.

RNA 104

RNA DNA Vaccine Virus 104

Drug & Device Law

FEBRUARY 15, 2024

Additionally, if applied retroactively, the revisions would impose a new duty on pharmaceutical drug manufacturers and sellers at the time the injury occurred, where none had existed before. Lynch & Co. Flex Techs., 2d 180, 182 (Mich. Nothing about retroactivity. This defies logic, fairness, and – unsurprisingly – due process.

Production 52

Production FDA Approval FDA Compliance 52

Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. Buckman Co.

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

OCTOBER 23, 2023

Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ). Ortho Pharmaceutical Corp. , 341 (2001), which put an end to any doubt about this proposition. at 328 (citation omitted). 2023 WL 6216933, at *7.

Government 59

Government Regulations FDA Nurses 59

Drug & Device Law

OCTOBER 20, 2023

LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. 341 (2001), is so important. FDA/Alliance for Hippocratic Medicine v.

FDA 59

FDA FDA Approval Clinical Trials Pharmaceuticals 59

Drug & Device Law

OCTOBER 10, 2023

Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” 341 (2001). Similarly, the court in Nexus Pharmaceuticals, Inc. That’s the FDA’s job, not the court’s. Plaintiffs’ Legal Comm. , See Telebrands , at *8-11.

FDA Approval 59

FDA Approval FDA Pharmacy Regulations 59

Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 379r(c)(2), Carter also quickly recognized that the OTC preemption “state requirement” prong includes state law causes of action, not just state legislation or regulations. 379r(a)(1). 379r(a)(1). 379r(a)(1).

Drugs 105

Drugs Regulations Production FDA Approval 105

Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 727 F.

FDA Approval 59

FDA Approval FDA Doctors Production 59

Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. This result threatens the integrity of the system of federal prescription medical product regulation that has served this country well for nearly a century. That’s why Buckman Co. E.g. , Estee Lauder, Inc.

FDA 52

FDA FDA Approval Doctors Production 52

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2001); Isham v. Medicis Pharmaceutical Corp. , 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. at 77 (citation omitted).

Production 52

Production Trials International Government 52

Drug & Device Law

JUNE 1, 2023

2001)); Turbyfill v. Merrell Dow Pharmaceuticals, Inc. , Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. 2001), pointing out that Idaho’s Rule 702 does not have the same language (it still does not). Union Pacific Railroad Co. , 3d 77, 83 (Ark. State , 53 S.W.3d 3d 56, 61 (Ark. State , 211 S.W.3d

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

FEBRUARY 20, 2023

151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. Here, Plaintiff concedes that some of the proposed designs. . .

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S.

FDA 72

FDA Regulations Production Government 72

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. Bayer Healthcare Pharmaceuticals Inc. 379r(e). Just compare the felicitous result in Truss v.

Regulations 59

Regulations FDA Nurses FDA Approval 59

Drug & Device Law

OCTOBER 27, 2022

2022), is neither a medical-device nor a pharmaceutical case. 341 (2001), the U.S. If, by contrast, the agency allowed choice for the convenience of regulated entities rather than to advance its own goals, then the state law escapes preemption under Williamson. The case we discuss today, Vaughan v. Biomat USA, Inc. Genzyme Corp.

FDA 59

FDA Licensing Licensing Regulations 59