Drug Patent Watch

JANUARY 9, 2025

A CDMO’s track record in delivering high-quality products can make or break your project. Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. Managing Scale-Up Challenges Scaling up production often comes with unexpected challenges.

Compliance

FDA Law Blog: Biosimilars

MAY 4, 2025

DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. IMC Pro did not store or handle the packages nor maintain records about their contents.

Packaging

Codon

NOVEMBER 1, 2024

They engineered genetically-encoded RNA exporters, based on viruses, that package and secrete RNA molecules in protective nanoparticles, allowing non-destructive monitoring of those RNA molecules in real-time. It demands protocols, regulations, and collaborative efforts between human beings.

DNA

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

Therapies

Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. These dedicated individuals play a critical role in ensuring that generic drugs meet the same high standards as their brand-name counterparts.

Drugs

FDA Law Blog: Biosimilars

APRIL 10, 2025

As it relates to the FDA, FOIA serves as a vital tool for stakeholders including patients, researchers, and regulated industry to better understand the Agencys scientific, policy and regulatory decision-making. FOIA is a U.S. In some cases, previously routine postings are delayed or going unpublished altogether.

FDA

The Pharma Data

JUNE 24, 2025

As the company continues to evolve its business model, reconfigure its operations, and expand its product portfolio, it remains firmly anchored in its mission “to Save and Sustain Lives.” This pilot effort included employee training on circularity principles and identified ways to apply these concepts to manufacturing and packaging.

Production

New Drug Approvals

JULY 18, 2025

The method requires a total of 15 steps of reaction to obtain the target product. Low cost, high cost, not suitable for industrial production. The crude product was purified by silica gel column chromatography (ethyl acetate: petroleum ether =1:10) to obtain a white solid (yield: 41.2%). Example 1 Accurately weigh 4.86

RNA

FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

Production

The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product.

Packaging

FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

Compliance

FDA Law Blog: Biosimilars

JULY 15, 2025

The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.

Compliance

The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., The drug product is packaged and shipped as a solid powder.

Production

KIF1A

OCTOBER 21, 2023

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. From Gabrych et al.

Regulations

FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

Regulations

Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware.

Regulations

FDA Law Blog: Biosimilars

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). not subject to premarket review).

FDA

biobide

NOVEMBER 20, 2023

The justification for this growth projection lies in the increased popularity and demand for skincare and personal care products, joined by the aging of global population. Such concerns have led to strict regulations regarding the formulation of cosmetic products.

Packaging

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. Products containing BPA encompass a wide range of applications. Stakeholders now have until March 8 to provide feedback on the proposal.

Packaging

FDA Law Blog: Biosimilars

JUNE 25, 2025

To be clear, the minor changes are permitted only for OTC monograph drug products that are included in deemed final orders, and not for OTC monograph products that may remain on the market pending FDA monograph orders allowing or prohibiting such products.) See 16 C.F.R.

FDA

Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Regulations

Agency IQ

NOVEMBER 20, 2023

EMA publishes first electronic Product Information as pilot progresses In 2022, the European Commission, Heads of Medicines Agencies and EMA established a common standard for electronic Product Information, or ePI, an electronic representation of information patients usually receive in paper format along with their medicines.

Production

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

Therapies

FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

Government

Agency IQ

AUGUST 30, 2024

By Scott Stephens, MPA In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. Fill out the form to read the full article.

Packaging

The Premier Consulting Blog

MAY 4, 2023

Given this trend, many biopharmaceutical companies are investing in strategies to develop and commercialize new or existing ophthalmic products that address unmet medical needs. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

FDA

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. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

Regulations

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. 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. The new § 820.10 Revised § 820.3

FDA

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. The Risk Assessment Committee (RAC) working group on applications of authorizations (RAC AfA WG) will meet on May 7 and the Biocidal Products Committee (BPC) will meet on May 27-31.

Regulations

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. ECHA has a slew of multiday meetings lined up for September , starting with meetings of the Risk Assessment (RAC), Biocidal Products (BPC), and Socio-economic Analysis (SEAC) committees from September 16 to 20.

Regulations

Agency IQ

AUGUST 25, 2023

As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. PFAS regulation in the E.U. Two high-profile initiatives to regulate PFAS in the E.U. years for products like industrial precision cleaning fluids to 6.5

Regulations

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.

Regulations

Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

Regulations

The Pharma Data

JULY 11, 2021

A separate analysis of patients with moderate to severe UC evaluated meaningful improvement of bowel urgency, a common symptom of UC that is associated with higher levels of disease activity, decreased work productivity and worse quality of life. ” Patients with UC Reported on Definition of Meaningful Change in Bowel Urgency.

Regulations

The Premier Consulting Blog

MAY 11, 2023

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. All regulated parties, including ophthalmic drug and device manufacturers, should take note. Unsurprisingly, the U.S.

FDA

Agency IQ

JULY 26, 2024

FDA finalizes guidance on electronic submissions for OTC products FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. These products are regulated differently from traditional prescription drugs.

FDA

Drug Target Review

JULY 7, 2023

The epigenome (meaning ‘above the genome’) is a system of reversible marks regulating how the DNA is read, translated and used. The molecular machinery of the epigenetic system can selectively package specific regions of DNA away, making them inaccessible and less active. We are on the precipice of a new era in genetic medicine.

DNA