Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. pharmaceutical law ceased to apply to the U.K. s single market. member states. s official exit from the E.U.

Packaging 40

Packaging Licensing Licensing Regulations 40

Conversations in Drug Development Trends

MAY 23, 2024

Regulatory Harmonization of Clinical Trials in the EU The EU-CTR repealed the Clinical Trial Directive 2001/20/EC (CTD) and national implementing legislation in the EU Member States on 31 January 2022. This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

Trials 52

Trials Clinical Trials Therapies Treatment 52

Agency IQ

MARCH 7, 2024

To keep critical devices and in vitro diagnostics (IVDs) available for patients in Great Britain (England, Scotland, and Wales), a much smaller market than the remaining 27 Member States of the E.U., post-market regulation here.] In the wake of Brexit, the E.U. no longer recognized products certified in the U.K., but the U.K.

Regulations 40

Regulations International Government Production 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

The Commission’s communication was accompanied by a Q&A document defining key terms and ideas, including how the effort was related to ongoing efforts to overhaul the pharmaceuticals legislation. Read AgencyIQ’s analysis of the Parliament discussion , the communication and establishment of the list of critical medicines.]

Regulations 40

Regulations Production Packaging FDA 40

Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S.

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

Agency IQ

JUNE 21, 2024

For products that seek approval through the “centralized marketing authorization application,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a scientific evaluation and issues a positive or negative opinion on whether an authorization should be granted. Conversely, authorization in specific E.U.

Regulations 40

Regulations Marketing Production Vaccine 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

Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

DECEMBER 15, 2023

April 2024 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program Proposed Rule Stage 2040-AG02 EPA supports market-based mechanisms, including water quality trading under the Clean Water Act (CWA). EPA plans to continue its outreach efforts with affected parties.

Regulations 40

Regulations Compliance Production Government 40

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. See Enriquez v.

FDA Approval 59

FDA Approval FDA Doctors Production 59

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. See Enriquez v.

FDA 52

FDA FDA Approval Doctors Production 52

Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. That’s a toxic mix, indeed, when combined with the plaintiffs’ bar’s latest concerted attempt to drive a form of birth control off the market through product liability litigation.

Government 59

Government Regulations FDA Nurses 59

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. , 341 (2001). Takeda Pharmaceutical Co. , 3d 1243 (9th Cir. Plaintiffs Legal Committee , 531 U.S.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 2001) (no warning causation notwithstanding heeding presumption where prescriber testified that “the risk of him having a problem due to his [condition] was much greater than him taking the [drug]”) (applying Oklahoma law); Porterfield v. 3d 203 (5th Cir.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2001); Isham v. Medicis Pharmaceutical Corp. , 2001), relied on these other statutes to hold that a road could not be a “product”). Leading Market Technologies, Inc. , 2001) (applying Illinois law); Serpico v. Paragon 28, Inc. 2019 WL 4751807, at *8 (D.

Production 52

Production Trials International Government 52

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

FDA 59

FDA FDA Approval Testimonials Vaccine 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

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

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & 2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been found inadmissible. . ., However, that do-over took a year and cost the defendant who knows how much money, headaches and heartburn.

Testimonials 52

Testimonials Production Vaccine Pharmaceuticals 52

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

JANUARY 9, 2023

Bayer Healthcare Pharmaceuticals Inc. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). This regulation specifies the precise language for “liver”-related warnings on acetaminophen-containing products marketed for adult use.

Regulations 59

Regulations FDA Nurses FDA Approval 59

Drug & Device Law

JANUARY 8, 2024

Forest Pharmaceuticals, Inc. 2001), aff’d , 303 F.3d E.g., In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation , 174 F. 3d , 2023 WL 8711617 (S.D.N.Y. 18, 2023), #5 Onglyza Products Cases , 307 Cal. 3d 480 (Cal. 2023), and #16 Daniels-Feasel v. 2023 WL 4837521 (2d Cir.

Production 52

Production Science Disease International 52

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

SEPTEMBER 1, 2023

As a result, they are not claiming a defect in design; they are not claiming that the drug warnings were inadequate; they are not claiming that TDF drugs should be withdrawn from the market; and they agree that TDF drugs have benefited and continue to benefit thousands of patients. So the plaintiffs pivoted. Superior Court , 44 Cal.

Production 64

Production Marketing Drugs Pharma Companies 64

Drug & Device Law

OCTOBER 10, 2023

341 (2001). So, if defendants had been marketing their products as FDA-approved when they were not, that claim may not be preempted as it does not require litigation of an FDCA violation. Similarly, the court in Nexus Pharmaceuticals, Inc. Plaintiffs’ Legal Comm. , See Telebrands , at *8-11. Nidek Co. ,

FDA Approval 59

FDA Approval FDA Pharmacy Regulations 59