Fierce BioTech

OCTOBER 8, 2024

Ana Kuschel Francis Carroll Sonia Adamidis Marc Uerdingen Duration 90 Minutes Join West experts to learn about solutions for today’s drug products and tomorrow’s novel applications and gain insights to understand and execute a risk-based critical thinking approach related to injectable drug packaging and delivery. Click here to login.

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Drugs.com

APRIL 16, 2024

TUESDAY, April 16, 2024 -- In the wake of a sharp rise in the number of young children accidentally eating melatonin supplements, an industry group has called for tougher safety guidelines for packaging and labeling the sleep-aid.

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Packaging 105

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.,

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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.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 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.

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 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.

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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.

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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,

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Packaging 97

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.

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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.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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. We’re about to find out.

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Common Sense for Drug Policy Blog

OCTOBER 29, 2024

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 dwf_admin Tue, 10/29/2024 - 14:01 Source Russell E, Hawk M, Neale J, et al. Published online September 17, 2024.

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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. These address classification and labeling harmonization (CLH) of dazomet (ISO) and occupational exposure limit (OEL) values for N-(hydroxymethyl)acrylamide, anthraquinone, butanone oxime, and acetone oxime.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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.

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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.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Under REACH, these address testing proposals for five entries, including trimethylolpropane diallyl ether and 5-(hydroxymethyl)-2-furaldehyde.

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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.

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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.

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Perficient: Drug Development

NOVEMBER 22, 2024

Starshot is a game-changer for organizations seeking to elevate their digital strategies, from scalable pre-packaged solutions to AI-driven personalization and seamless updates. Pre-Packaged Recipes for Instant Results Gone are the days of configuring every element of your website from scratch.

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Packaging Compliance Marketing Research 52

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.

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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.”

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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.

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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.

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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.

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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.

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Broad Institute

JULY 10, 2024

Next, researchers will need to develop ways to package and deliver the prime editing machinery to the airways in mice and ultimately humans. Online July 10, 2024. The new approach also generated 3.5 times fewer unwanted insertions and deletions per edit than previous methods that use the Cas9 nuclease enzyme.

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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

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Broad Institute

AUGUST 7, 2024

Machine learning approach helps researchers design better gene-delivery vehicles for gene therapy By Allessandra DiCorato August 7, 2024 Breadcrumb Home Machine learning approach helps researchers design better gene-delivery vehicles for gene therapy The method could accelerate the development of more effective adeno-associated viruses (AAVs).

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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.

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FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. Comments are due by December 12, 2024. By Deborah L.

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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.

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Drugs Packaging Compliance Drug Development 52

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.

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PPD

NOVEMBER 11, 2024

According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8 From an aging population increasing health care demand to urgent, unmet medical needs, there are clear drivers to advance safe and effective medicines to patients faster than ever. billion in 2035.

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Alta Sciences

NOVEMBER 5, 2024

Their advantages include ease of scalability and manufacturing, ease of packaging, and high product stability. This blog was originally posted 07/26/2021 and updated on 11/05/2024 Reference [link] Image Thumbnail_Blog-LFHSCs-alt.jpg Synopsis Liquid-filled capsules can be rapidly developed and tested, moving quickly from R&D to clinic.

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Marketing Small Molecule Production Pharmaceuticals 52

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.

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Agency IQ

JULY 12, 2024

BY WALKER LIVINGSTON, ESQ | JUL 11, 2024 6:28 PM CDT Background: PFAS and TSCA Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been in use since the 1940s. On April 18, 2024, the EPA announced receipt of the petition and stated that the agency would grant or deny the petitions by July 10, 2024.

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