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 59

FDA Regulations Packaging Compliance 59

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. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

Regulations 40

Regulations Production Government Packaging 40

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

Regulations 40

Regulations Production Packaging International 40

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 consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

Regulations 40

Regulations Production Packaging Science 40

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

Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

Regulations 40

Regulations Production International Marketing 40

FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

Packaging 59

Packaging FDA Production Regulations 59

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

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Today, the U.S. We will continue to work to protect consumers.”. 1, 2021, through the present. 29 and Sep.

Production 52

Production FDA Packaging Regulations 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

Drugs 59

Drugs Regulations International Production 59

The Pharma Data

MAY 17, 2021

JAMA Intern Med Gyawali et al. JAMA Intern Med Gunter et al. . Posted 17 May 2021 | By Jeff Craven . Although the UDI was enacted with good intentions, the FDA was wise to end it,” Gunter and colleagues concluded. © 2021 Regulatory Affairs Professionals Society. Source link.

Research 52

Research FDA Approval Drugs FDA 52

Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

Regulations 40

Regulations International Packaging Compliance 40

National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Great progress has been made in reducing smoking in the United States, which has led to major improvements in health, but the rapidly growing vaping industry, if not properly regulated, could jeopardize this. JAMA Internal Medicine. Associations between screen time and internalizing disorder diagnoses among 9- to 10-year-olds.

Drugs 106

Drugs Production Science Marketing 106

Agency IQ

JULY 12, 2024

EPA grants petition on PFAS in fluorinated containers Following a loss at the Fifth Circuit, the EPA has a new plan to regulate PFAS in fluorinated plastic containers: traditional Toxic Substances Control Act Section 6 rulemaking. On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA.

Regulations 40

Regulations Packaging Production Government 40

The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Pascal Soriot, CEO of AstraZeneca, pictured above.

Vaccine 52

Vaccine Virus Trials Regulations 52

Agency IQ

FEBRUARY 12, 2024

Lack of international harmonization is a challenge for generic products. The International Council for Harmonization (ICH) has developed limited standards for generic drugs, such as the M13 guideline on bioequivalence for immediate-release solid oral dosage forms [ Read AgencyIQ’s detailed analysis of that document here here. ]

FDA 40

FDA Packaging Production International 40

Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance 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. REACH, CLP, BPR, PIC), scopes (e.g.,

Compliance 40

Compliance Regulations Packaging Production 40

Codon

FEBRUARY 13, 2024

A BBC documentary on ‘The Virus that Cures’ was broadcast around the world in 1997, and in the former communist party headquarters in Georgia, American investors helped organize the first major international conference on phage therapy since the 1930s.

Therapies 124

Therapies Virus DNA Clinical Trials 124

The Pharma Data

MAY 14, 2021

When you drink, the liver has to work to remove the alcohol from the blood instead of regulating blood sugar. I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for CLICK NOW TO SECURE YOUR PACKAGE WHILE SUPPLIES LAST!

Packaging 52

Packaging Production Compliance Regulations 52

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. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.

Regulations 40

Regulations Packaging Production Doctors 40

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.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 31, 2021

Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. Mark Swallow , David Dible – International Media +44 (0)20 7638 9571 | SoseiHeptares@citigatedewerogerson.com. ” About Sosei Heptares.

Structure Based Drug Design (SBDD) 52

Structure Based Drug Design (SBDD) Targeted Protein Degradation Drugs Disease 52

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation. Existing published VCS may be identified internally by FDA or externally by stakeholders. Consensus does not require unanimity, but a general agreement.

Therapies 59

Therapies FDA Production Regulations 59

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

The Pharma Data

OCTOBER 19, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. Please read more here. .

Vaccine 52

Vaccine Virus FDA Clinical Trials 52

Agency IQ

DECEMBER 15, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation. for uses under TSCA.

Packaging 40

Packaging Regulations Government Production 40

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.

FDA 40

FDA Science Regulations Biosimilars 40

NIH Director's Blog: Drug Development

MARCH 11, 2014

In an unprecedented effort aimed at finding and validating new therapeutic targets for T2D, an international team led by NIH-funded researchers recently analyzed the DNA of about 150,000 people across five different ancestry groups. NIH/NIDDK) [5] The diabetes-susceptible gene SLC30A8/ZnT8 regulates hepatic insulin clearance.

DNA 52

DNA Drugs Disease Research Laboratories 52

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

Advarra

JUNE 14, 2024

Protocol and amendments Purpose: To document revisions of trial-related documents during the trial Documents: Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments Informed consent documents Purpose: (..)

Clinical Trials 40

Clinical Trials Trials Compliance FDA 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 Marketing Packaging 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

Codon

APRIL 23, 2024

The yeast cells synthesize lots of sugars to regulate their internal osmotic pressure and also attach sugars to proteins to stabilize them against damage caused by the perchlorates. The entire planet is basically a desiccant, akin to those white packets found in packages of beef jerky that say “Do not eat.”

Engineering 88

Engineering DNA Hospitals International 88

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

FDA 40

FDA FDA Approval Production Regulations 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 86

Engineering Vaccine Production RNA 86

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to the FDA, delays arose due to issues with international inspections during the pandemic.

FDA 40

FDA Drugs Production Licensing 40