Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. Amanda Conti, AgencyIQ What kind of biologic products entered the market? Industry has historically struggled to fulfill (or be incentivized to fulfill) post-market requirements (PMRs) in general.

FDA 52

FDA Biosimilars Science Production 52

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. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

Packaging 40

Packaging Licensing Licensing Regulations 40

The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. Tax Court to contest notices of deficiencies received from the IRS during the quarter for 2010, 2011 and 2012.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Delays In the early 1980s, eager to push artemisinin onto the international market, China turned to the World Health Organization (WHO).

Drugs 129

Drugs Science Research Doctors 129

Agency IQ

MARCH 1, 2024

Proposal for a Regulation Initiative entry Preventing terrorism – new rules on the marketing and use of high-risk chemicals Adoption was planned for third quarter of 2023 This initiative establishes rules on the marketing and use of high-risk chemicals. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Production Packaging Science 40

Agency IQ

SEPTEMBER 29, 2023

On October 5, the European Parliament (EP) plenary is scheduled to debate and likely vote on its position on the proposed regulation for reforming Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Packaging Production International 40

Agency IQ

DECEMBER 1, 2023

Proposal for a directive Initiative entry Preventing terrorism – new rules on the marketing and use of high-risk chemicals Adoption was planned for third quarter of 2023 This initiative establishes rules on the marketing and use of high-risk chemicals. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Production International Marketing 40

Agency IQ

OCTOBER 27, 2023

aligns the rules with other EU chemicals legislation – notably on biocidal products and classification, labeling and packaging. food packaging, kitchen and tableware and food processing equipment). This initiative proposes amending the list of restricted substances in Annex III to Directive 2011/65/EU.

Regulations 40

Regulations Production Packaging International 40

Agency IQ

FEBRUARY 2, 2024

Proposal for a Regulation Initiative entry Preventing terrorism – new rules on the marketing and use of high-risk chemicals Adoption was planned for third quarter of 2023 This initiative establishes rules on the marketing and use of high-risk chemicals. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

JULY 22, 2024

AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database. While the total number of novel drugs dipped to 37 in 2022, the agency recovered with 55 approvals in 2023, the second highest in a calendar year since 2011. [

Clinical Trials 52

Clinical Trials Trials Science FDA 52

Agency IQ

JANUARY 4, 2024

The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments.

Regulations 40

Regulations Packaging Production Government 40

LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g.,

Small Molecule 52

Small Molecule Computational Chemistry Engineering Clinical Development 52

Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

Regulations 40

Regulations Production Compliance Science 40

Agency IQ

OCTOBER 27, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

Regulations 40

Regulations Compliance Science Production 40

Agency IQ

MARCH 29, 2024

Similarly, the Group I and II Polymers and Resins NESHAP were most recently updated when the agency conducted its RTR on December 16, 2008, and April 21, 2011. The HON standards were most recently updated when the agency conducted a residual risk and technology review (RTR) on December 21, 2006.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

Regulations 40

Regulations Production Packaging Treatment 40

The Pharma Data

MAY 13, 2021

Meanwhile, a 2011 study from Drexel University found that African Mango: “Is effective in reducing body weight and improving metabolic parameters in overweight humans”…xxxiii. That would sound better from a marketing perspective. Dr. Wood doesn’t care very much about slick marketing…. Once you’ve selected your package….

Production 52

Production Packaging Doctors Research 52

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. Similarly, the Group I and II Polymers and Resins NESHAP were most recently updated when the agency conducted its RTR on December 16, 2008, and April 21, 2011.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

Manufacturers (including importers) who have manufactured these chemical substances in any year since January 1, 2011, would be subject to the reporting and recordkeeping requirements. For increased flexibility in bringing PIPs to market, a developer can also submit both. Proposed Rule Stage San Joaquin Valley PM2.5

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2011 WL 13186258, at *2 (C.D. May 17, 2011) (flight simulator and associated training materials were not products subject to strict liability); Heindl v. Leading Market Technologies, Inc. , Wells Fargo Bank , 2011 WL 1833020 (D. Gray Loon Outdoor Marketing.

Production 52

Production International Trials Government 52

Drug & Device Law

DECEMBER 29, 2023

F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation , 65 F.4th Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

MAY 30, 2022

1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J. Johnson & Johnson , 2011 WL 3876997 at *11 (S.D. 31, 2011), aff’d , 483 Fed.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

2011) (no causation where “at the time of her deposition ? the very same illness for which she treated Plaintiff”); In re Trasylol Products Liability Litigation , 2011 WL 2117257, at *5 (S.D. May 23, 2011) (no causation where prescriber “testified. . . GlaxoSmithKline , 2011 WL 6001864, at *3 (D. 2d 1254, 1261 (S.D.

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

SEPTEMBER 12, 2022

c)(6-7), and, as to this drug, the defendant itself filed a CBE supplement in 2011 and was allowed to add depression as an adverse reaction. The group requested that the FDA either withdraw marketing approval. . . Both propositions are well recognized, but Pfaff ties them together in one neat package. citations omitted).

FDA 59

FDA FDA Approval Regulations International 59

Drug & Device Law

FEBRUARY 19, 2024

Often, if not always, the “special controls” for a given FDA regulated product will specify that said product can only be marketed for prescription use and is thus exempt from providing “adequate directions for use” to lay patients. 201.100(a-b). Such special controls are preemptive. E.g. , 76 Fed. 6551, 6553 (FDA Feb.

Licensing 52

Licensing Licensing Regulations FDA 52

Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. The allegations that the NDA holder had marketed the drug off-label were not new and it did not appear that they claimed some new injury or risk compared to past plaintiffs were preempted claims. Plaintiffs did not even complain about the content of the package insert. Mensing , 564 U.S.

Doctors 52

Doctors Packaging FDA FDA Approval 52

Drug & Device Law

FEBRUARY 2, 2022

The parents sued, claiming that confusing packaging made them buy a bottle without a child-proof cap. By the reception desk there was a glass cabinet containing OTC drug packages that the state had concluded were unduly confusing. The point is that there was nothing deceptive about the infants’ and childrens’ product packaging.

Marketing 59

Marketing Packaging Production FDA 59