Drugs.com

MARCH 12, 2024

TUESDAY, March 12, 2024 -- Be sure to check your fridge for any Johnsonville turkey kielbasa sausage -- over 35,000 pounds of the product is under recall due to some customers finding "pieces of rubber" in the packaged meat. Denmark, Wisc.-based.

Packaging 98

Packaging Production 98

Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Name CAS RN Hazard endpoint proposed for vertebrate testing Deadline 10 testing proposals for seven chemical entries, including for dibromomethane, diethyl succinate, and triisobutyl phosphate.

Regulations 40

Regulations Packaging Production International 40

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. BY SCOTT STEPHENS, MPA | FEB 12, 2024 10:42 PM CST Bisphenol A (CAS No. The substance has a harmonized classification entry (i.e.,

Packaging 40

Packaging Regulations Compliance Production 40

Drugs.com

FEBRUARY 12, 2024

12, 2024 -- Think twice if you're pregnant and craving a packaged pastry or a take-out burger and shake.That indulgence can do more than cause unwanted weight gain. MONDAY, Feb. A new study shows that phthalates, chemicals associated with plastics,

Packaging 91

Packaging 91

Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. This edition reviews developments that occurred in late 2023 and early 2024.

Regulations 40

Regulations Packaging Production Doctors 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

Regulations 40

Regulations Production International Government 40

Drug Discovery World

SEPTEMBER 13, 2023

The latest investment package follows a strong 18 months for the company, which more than doubled revenues in 2022 and has already secured substantial contracts with major pharma and biopharmaceutical companies for 2023 and 2024.

Clinical Trials 130

Clinical Trials Trials Packaging Marketing 130

Drug Discovery World

JUNE 17, 2024

The money is there but investors are being more selective about who they back. Fortunately, just like the weather, it looks as if things are looking up for the sector as we go into the second half of 2024. About the author Y ogan A Patel is a Partner at MHA and Head of MHA’s Pharma, Life Science and Med-Tech sector group.

Packaging 147

Packaging Science Marketing International 147

Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. 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.

Regulations 40

Regulations Packaging Production Government 40

Broad Institute

MARCH 19, 2024

Researchers roll out a more accurate way to estimate genetic risks of disease By Claire Hendershot March 19, 2024 Breadcrumb Home Researchers roll out a more accurate way to estimate genetic risks of disease Two new approaches for generating polygenic scores demonstrate that compiled data improves score accuracy. Online March 19, 2024.

Disease 136

Disease Research Packaging Hospitals 136

Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Compliance Production Government 40

Fierce BioTech

MAY 2, 2024

In this webinar, you will learn about: The challenges and risks related to the packaging and filling of high-value drug products. On Demand Start Date Wed, 06/12/2024 - 12:00 Listing Image WEST_ListingLogo_250x190.png

Therapies 52

Therapies Packaging Pharmaceuticals Production 52

Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA is receiving comments until the end of March on one substance being considered for exemption. The European Green Deal sets out the ambition to reach zero pollution for a toxic-free environment.

Regulations 40

Regulations Production Packaging Science 40

Alta Sciences

APRIL 6, 2024

Strategies for Safe and Timely Shipments blussier Sat, 04/06/2024 - 23:35 HTML Your Samples Are in Good Hands With Us! From regulatory precision to preserving sample integrity, shipments can be challenging.

Packaging 52

Packaging Compliance 52

Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Compliance Government Science 40

Broad Institute

JANUARY 8, 2024

Williams January 8, 2024 Credit: Susanna Hamilton, Broad Communications Researchers have developed virus-like particles that can deliver gene-editing cargo to cells, including those in the mouse brain. Online January 8, 2024. By Sarah C.P. Paper cited: An, M. Nature Biotechnology.

Engineering 144

Engineering Research DNA Virus 144

FDA Law Blog: Biosimilars

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

FDA 52

FDA Packaging Production Compliance 52

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. increase in base salaries for federal workers in 2024, which started in January.

FDA 40

FDA Packaging Science Drugs 40

Agency IQ

MARCH 15, 2024

BY WALKER LIVINGSTON, ESQ | MAR 13, 2024 2:33 PM CDT Background: CalRecycle and plastic waste regulations in California The California Department of Resources Recycling and Recovery (CalRecycle) oversees the state’s initiatives towards reducing waste and reusing materials. That amount will increase to 40% in 2030 and 65% in 2032.

Regulations 40

Regulations Packaging Compliance Production 40

Agency IQ

MAY 10, 2024

BY WALKER LIVINGSTON, ESQ | MAY 7, 2024 10:50 PM CDT Background: PFAS Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since the 1940s. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

Packaging 40

Packaging Regulations Production Compliance 40

Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

Packaging 52

Packaging Compliance Drugs Drug Development 52

The Premier Consulting Blog

APRIL 27, 2023

applications from any sponsors who choose to use it in Q1 of 2024, and by 2028, it will be required in the US for all sponsors. Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 The agency will begin accepting eCTD v4.0

Packaging 52

Packaging FDA International Pharmaceuticals 52

Broad Institute

MAY 16, 2024

By Allessandra DiCorato May 16, 2024 Credit: Deverman lab Brain vasculature (in blue) surrounded by RNA (in orange) transcribed from the gene delivered to the brain in humanized mice using an engineered AAV targeting the human transferrin receptor. Online May 16, 2024. Paper cited Huang Q, Chan KY, et al. DOI: 10.1126/science.adm8386.

Therapies 137

Therapies FDA Approval Engineering Disease 137

Broad Institute

JUNE 27, 2024

By Greta Friar, Whitehead Institute June 27, 2024 Images of a mouse brain show the effect of a technology called CHARM in turning off the expression of a gene in the brain. The first problem they had to tackle was the editor’s size, because the editor needs to be small enough to be packaged and delivered to specific cells in the body.

Disease 137

Disease Therapies Engineering Clinical Trials 137

The ChEMBL-og

APRIL 16, 2024

New data have been included in the VERSION table to show the version applied for MeSH and EFO ontologies, the ChEMBL_Structure_Pipeline, RDKit packages, InChI, UniProtKB, Bioassay Ontology and Gene Ontology as well as the version of the ChEMBL database. Data set retrieved on 09/02/2024. University of Dundee: T.

Clinical Trials 110

Clinical Trials FDA Cell Based Assays Packaging 110

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

Pharmaceuticals 40

Pharmaceuticals Packaging Regulations Production 40

Agency IQ

FEBRUARY 23, 2024

NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. BY WALKER LIVINGSTON, ESQ | FEB 22, 2024 2:52 PM CST Background: PFAS Per- and polyfluoroalkyl substances (PFAS) are a wide range of synthetic organic chemicals that have been produced since the 1940s.

Packaging 40

Packaging Regulations Production Compliance 40

Agency IQ

AUGUST 4, 2023

These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. only” labeling should be implemented for both these product types immediately but no later than December 31, 2024. only” label can be affixed anywhere on the packaging. As a quick reminder, the U.K.

Packaging 40

Packaging Licensing Licensing Regulations 40

Agency IQ

JUNE 21, 2024

Key Documents and Dates Highlights from June RAC and SEAC meetings , June 13, 2024 Minutes of the 69th Meeting of the Committee for Risk Assessment , June 10, 2024 At their November meetings, the two committees will discuss fluorinated gas applications; as well as applications related to transport and construction products.

Packaging 40

Packaging Production Regulations 40

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

FDA 59

FDA Regulations Packaging Compliance 59

Broad Institute

FEBRUARY 21, 2024

By Claire Hendershot February 21, 2024 Credit: Allison Colorado, Broad Communications Khalid Shakir is a principal software engineer in the McCarroll Lab. I’ll say I’m excited about interactive visualizations, which are built on top of open source plotting packages such as R.

Engineering 116

Engineering Research Science Bioinformatics 116

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). 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”. The report recognized the potential for an electronic format for Product Information (i.e.,

Production 40

Production Packaging Regulations Hospitals 40

Agency IQ

JUNE 17, 2024

BY SCOTT STEPHENS, MPA | JUN 10, 2024 10:26 PM CDT Switzerland and the EU’s impact on Swiss chemical regulations Though located in the heart of Europe, Switzerland is not a member of the European Union , nor of the European Economic Area (EEA). The adaptations to Annexes 2 and 3 of ChemV are expected to enter into force on September 1, 2024.

Regulations 40

Regulations Production International Packaging 40

Agency IQ

MARCH 15, 2024

BY SCOTT STEPHENS, MPA | MAR 13, 2024 4:22 PM CDT Regulatory background Per- and polyfluoroalkyl substances (PFAS), which are commonly used in textiles, impregnation agents, paints, firefighting foams (AFFF) and many other applications, have been linked to an increased risk of certain cancers, developmental effects and immunosuppression.

Regulations 40

Regulations Packaging Production 40