PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

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Packaging Laboratories Pharmaceutical Companies Compliance 52

The Pharma Data

MAY 18, 2021

GSK Consumer Healthcare (GSKCH), the world-leading consumer healthcare business, announced today that it is partnering with two global packaging suppliers to launch fully recyclable toothpaste tubes across its specialist and science-based oral health brands, including Sensodyne, parodontax and Aquafresh. Best’ in Germany.

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Packaging Science Marketing Production 40

Fierce BioTech

JANUARY 3, 2025

This joint webinar presentation by West and Groninger, explores the unique challenges of Cell and Gene Therapies, mRNA LNP therapeutics particularly regarding cold storage requirements and their impact on packaging solutions. On Demand Start Date Wed, 02/12/2025 - 11:00 Listing Image WestPharma_ListingLogo_250x190.png

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Packaging Therapies Pharmaceuticals Treatment 52

Fierce BioTech

JANUARY 3, 2025

Innovations in aseptic processing for container closure systems dwunderlin Fri, 01/03/2025 - 14:26 Wed, 02/12/2025 - 10:00 Resource Type Webinar Jim Thompson Julian Petersen Duration 60 Minutes The pharmaceutical landscape is shifting from blockbuster drugs to personalized treatments, driving the need for innovative container closure systems.

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Packaging Therapies Pharmaceuticals Treatment 52

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Member states are to draft penalties for non-compliance by June 30, 2025. The proposed regulation is divided into 9 chapters.

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Packaging Regulations Laboratories Animal Testing 40

FDA Law Blog: Biosimilars

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

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Compliance Packaging Regulations FDA 59

The Pharma Data

SEPTEMBER 6, 2021

The company is piloting this with its Dr.BEST GreenClean toothbrush, which builds new sustainable handle technology onto its previous innovations with sustainable bristles and packaging. The product’s 100% plastic free packaging includes GSKCH’s innovative cellulose window (which is also made with renewable cellulose.

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Packaging Production Science Marketing 52

Agency IQ

AUGUST 4, 2023

on June 20, 2023 and will apply starting January 1, 2025. These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. Beginning January 1, 2025, the MHRA will be responsible for authorizing all medicines for the U.K. The label must state the words “UK only.”

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Packaging Licensing Licensing Regulations 40

The Premier Consulting Blog

APRIL 27, 2023

Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 The agency will begin accepting eCTD v4.0 How can you prepare? ICH electronic Common Technical Document – eCTD v4.0

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Packaging FDA International Pharmaceuticals 52

Broad Institute

MAY 14, 2025

Cas9 ancestor engineered into a compact genome editing tool By Tom Ulrich May 14, 2025 Breadcrumb Home Cas9 ancestor engineered into a compact genome editing tool Researchers adapt a compact RNA-guided enzyme from bacteria for a variety of DNA editing tasks in human cells. Online May 7, 2025. Nature Biotechnology.

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Engineering DNA RNA Therapies 59

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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Production Compliance Regulations FDA 64

Perficient: Drug Development

MARCH 19, 2024

I got an email from Google Cloud Platform today entitled: [Action Required] Upgrade to Artifact Registry before March 18, 2025 This is not the first time Google has discontinued a product I use. The main driver behind the name change it seems is that Artifact Registry can manage more than just containers, such as OS and language packages.

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Packaging Production 52

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.,

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Production Packaging Hospitals Regulations 40

Agency IQ

SEPTEMBER 15, 2023

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. Since that time, the EPA has published additional drafts of the PHGs.

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Regulations Packaging Production Organic Chemistry 40

Agency IQ

FEBRUARY 23, 2024

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. 2030 is a short timeframe for compliance in supply chains.

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Packaging Regulations Production Compliance 40

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. Prescription Drug User Fee Rates for Fiscal Year 2025.

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Drugs Pharmacokinetics FDA Production 52

Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. If passed, the law would go into effect in January 2025.

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Packaging Production Regulations Compliance 40

LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Instead, it was based on the large unmet need, the advantages of a unique ADC-based delivery platform, and a strong preclinical data package that supported this strategy. Was that only six months ago?

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Clinical Trials Trials Disease Treatment 80

Agency IQ

JUNE 21, 2024

At that time, only the Dutch competent authority (one of the five dossier submitters) speculated about the end of the process, stating that the ban was “expected to enter into force in 2025.”

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Packaging Production Regulations 40

Agency IQ

SEPTEMBER 15, 2023

of the California Safe Drinking Water and Toxic Enforcement Act of 1986, the European Union’s (EU) Regulation on the Registration, Evaluation, Authorization of Chemicals ( REACH, 1907/2006 ), and the EU’s Classification, Labeling, and Packaging Regulation ( CLP 1272/2008 ), among others. The ban will become effective on January 1, 2025.

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Regulations Packaging Production Government 40

Agency IQ

FEBRUARY 12, 2024

In the theme of the planned rule to add additional PFAS to the TRI for 2025 mentioned above, the EPA officially completed the process to add seven PFAS to the TRI on January 9, 2024. 601 , seeks to prohibit PFAS (and other chemicals) for use in materials in packaging and packaging components. Another one of the bills, H.601

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Regulations Packaging Production Doctors 40

Perficient: Drug Development

JANUARY 14, 2025

Perficient’s Front-End Team concluded the year with a memorable meetup filled with inspiring sessions and networking, setting the stage for an exciting 2025. Let me take you through the event that perfectly wrapped up 2024! We’re already excited about the next one!

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Packaging Production 52

Agency IQ

MARCH 15, 2024

At that time, only the Dutch competent authority (one of the five dossier submitters) ventured to speculate about the end of the process, stating that the ban was “expected to enter into force in 2025.” The agency stresses that the individual steps in this process will be announced in parallel with the committee meetings.

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Regulations Packaging Production 40

Agency IQ

JUNE 7, 2024

The Commission will then republish an updated version of the list by March 19, 2025. Next, companies will have until June 19, 2025, to request that listed substances that they wish to obtain approval for be included in the Commission’s work program for review.

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Regulations Animal Testing Production Marketing 40

Agency IQ

JULY 26, 2024

Affected stakeholders will then have until January 1, 2025, when the regulation begins to apply, to prepare for compliance with the requirements triggered by the listing of the new substances in annexes I and V of PIC Regulation. Chemical CAS RN (or EC No.)

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Regulations International Packaging Compliance 40

Agency IQ

JULY 28, 2023

The Maine legislature has pushed back its compliance date for reporting on PFAS-containing consumer products to January 1, 2025. Vermont has prohibited the manufacture, supply, and distribution of food packaging, rugs and carpets, ski wax, and water resistant treatments with intentionally added PFAS.

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Regulations Packaging Compliance Treatment 40

Broad Institute

MAY 27, 2025

Gene editing disrupts Huntingtons mutation in mice By Allessandra DiCorato May 27, 2025 Breadcrumb Home Gene editing disrupts Huntingtons mutation in mice Making single-letter edits in stretches of repeated DNA stopped or reversed the genetic change that causes Huntingtons disease and Friedreichs ataxia. Online May 26, 2025.

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DNA Disease Packaging Research 130

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

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FDA Science Regulations Production 40

Broad Institute

JANUARY 14, 2025

By Allessandra DiCorato January 14, 2025 Credit: Maria Nemchuk, Broad Communications Eric Minikel and Sonia Vallabh run a lab with a singular focus: preventing and treating prion disease within their lifetime. Online January 14, 2025. But the researchers needed to deliver the base editors to the brain. Nature Medicine.

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Disease DNA Protein Production Treatment 144

Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

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Regulations Clinical Trials Production Biosimilars 40

Agency IQ

AUGUST 11, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. Moving forward, confirmatory testing for approved products should be completed by August 1, 2025.

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FDA Science Production Regulations 40

Agency IQ

AUGUST 23, 2024

On August 22, FDA finalized guidance that would require all De Novo applications to be provided in eSTAR format as of October 2025. As many commenters noted in the ML-DSF draft guidance docket, CDRH is moving towards requiring submissions in its electronic submissions template and resource (eSTAR).

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Science FDA Marketing Production 40

Codon

JUNE 5, 2025

pyogenes protein — whose compactness makes them far easier to package into viral vectors and deliver into the human body. In February 2025, base editors were used in the first-ever personalized CRISPR medicine , in which a five month-old infant was treated for a severe disease called carbamoyl-phosphate synthetase 1 deficiency.

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DNA RNA Clinical Trials Engineering 72

Agency IQ

JULY 22, 2024

AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database. Data on these novel approvals is published throughout the year by both CDER and CBER.

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Clinical Trials Trials Science FDA 52

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits.

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Regulations FDA Science Production 40

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity.

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Regulations Clinical Trials Production Trials 40

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. Spring 2025. TOKYO , Jan.

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Packaging Small Molecule Production FDA Approval 52