Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

FDA 40

FDA Regulations Production Packaging 40

Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

Therapies 117

Therapies DNA Virus Clinical Trials 117

Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

Regulations 40

Regulations Production Packaging Marketing 40

Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

FDA 40

FDA Regulations Packaging Marketing 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering 84

Engineering Vaccine Production RNA 84

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., At that time the Nimbus Board discussed the next chapter of our company.

Small Molecule 40

Small Molecule Computational Chemistry Engineering Clinical Development 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. GSK has built an industry-leading and high-performing Vaccines business, which has increased revenues from £4.6billion in 2016 to £7.0billion in 2020, and is expected to deliver high single digit % sales CAGR in 2021-26.

Government 52

Government Vaccine Production Science 52

Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. Hepatitis C used to be really difficult to treat, and those treatments had high failure rates, but DAAs revolutionized the field.

Vaccine 110

Vaccine Trials Disease Treatment 110

Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.”

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.”

Therapies 52

Therapies RNA DNA Engineering 52

Agency IQ

JULY 13, 2023

Consequently, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and flooring felt, rollboard, and corrugated, commercial, or specialty paper. On June 22, 2016, the “Frank R. However, the majority of this ban was overturned by Corrosion Proof Fittings v.

Production 40

Production Packaging Regulations Disease 40

The Pharma Data

FEBRUARY 22, 2021

2016 Mar;22(3 Suppl):s51-60. RINVOQ (upadacitinib) [Package Insert]. Mayo Clinic. Available at: [link]. Accessed on February 12, 2021. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. ClinicalTrials.gov. Available at: [link]. Accessed on February 12, 2021. North Chicago, Ill.

Disease 52

Disease Treatment Therapies Trials 52

The Pharma Data

NOVEMBER 2, 2020

To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Oncopeptides based on foreign tax regulations. per cent on a fully diluted basis. per cent on a fully diluted basis.

Marketing 40

Marketing Regulations Packaging Pharmaceutical Companies 40

Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Some speakers and participants mentioned that many patients are looking for efficacy when they participate in phase I trials, so what can sponsors and regulators do to achieve that? A lot of times the lower dose wins, right?

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. carpets, fabrics, and food packaging) and in specialty chemicals (i.e. BY PATRICIA ISCARO, ESQ. | OCT 11, 2023 7:05 PM CDT What are PFAS?

Regulations 40

Regulations Production Packaging Treatment 40

Codon

JUNE 26, 2023

In 2016, Belmonte “reported that sick mice lived 30% longer than expected after receiving a cocktail of special reprogramming proteins,” according to the article in MIT Technology Review. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) They’re incredibly versatile.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

In 2016, Belmonte “reported that sick mice lived 30% longer than expected after receiving a cocktail of special reprogramming proteins,” according to the article in MIT Technology Review. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) They’re incredibly versatile.

DNA 52

DNA Therapies Engineering Clinical Trials 52

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. PFAS regulations for drinking water.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 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. section 7412(d)(6). Pursuant to the D.C.

Regulations 40

Regulations Production Compliance Science 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA risk management rules.

Regulations 40

Regulations Compliance Science Production 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. For example, a 2016 study in the Journal of Environmental Health found that supplementing with these minerals led to higher levels of T3 and T4 in the bloodstream…iv. Along with the amount of estrogen-regulating DIM that he added as well. money back guarantee.00.

Production 52

Production Packaging Doctors Research 52

The Premier Consulting Blog

APRIL 27, 2023

Starting in 2016, many versions were developed through internal collaboration and change requests until, in 2022, eCTD v4.0 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

Packaging 52

Packaging FDA International Pharmaceuticals 52

Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes. DARWIN EU).

Science 40

Science FDA Research Regulations 40

Agency IQ

FEBRUARY 2, 2024

What we expect the EPA to do in February 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. The Agency expects to issue a final rule later in 2023.

Regulations 40

Regulations Compliance Engineering Government 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

Drug & Device Law

MARCH 11, 2024

115 (2016) (initially discussed here ), the Supreme Court drove a stake through the heart of the misbegotten “presumption against preemption” in express preemption cases. [B]ecause 115 (2016). 4th at 991, even though the relevant federal regulator (the EPA) did not require any such warning. In Puerto Rico v. Lohr , 518 U.S.

Regulations 52

Regulations Government Production Packaging 52

Drug & Device Law

JANUARY 4, 2024

115, 125 (2016). 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). [B]ecause Puerto Rico v. Franklin-California Tax-Free Trust , 579 U.S.

Vaccine 59

Vaccine FDA FDA Approval Production 59

Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2016) (citations omitted). 2016) (citation and quotation marks omitted). ADT, LLC , 2016 WL 3208483, at *3 (N.D. June 10, 2016); GCube Insurance Services., 2016 WL 6836950, at *4 (C.D.

Production 52

Production International Trials Government 52