FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA replied that its definition of strength including concentration was clear even in 2009. FDA explained that its bioequivalence regulations at 21 C.F.R.

FDA

thought leadership

JULY 2, 2024

This EU portal is established as part of the new Clinical Trial Regulation No. In this respect, a clinical trial with a GMO must also comply with either the contained use Directive (2009/41/EC) or the deliberate release Directive (2001/18/EC).

Trials

FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. FDA failed on each count.

FDA

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

The Pharma Data

AUGUST 21, 2020

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments.

FDA Approval

FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. The “review phase” is the period between the initial submission and approval of the NADA.

FDA

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations

The Pharma Data

AUGUST 28, 2020

In addition, the consultation – which seeks to amend the Human Medicine Regulations 2012 – will look into ways to protect companies that manufacture and distribute the vaccine, should it cause any harm. Source link.

Vaccine

Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. 2009 Mar 5;323(5922):1722–5. References Chen GY., Tang J, Zheng P, Liu Y.

Immune Response

Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2009 Sep;14(17–18):876–84. Regul Toxicol Pharmacol RTP. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. 2018;53(4):519–25.

Drugs

Drug Target Review

FEBRUARY 28, 2024

Previously, Mr Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co. Regulation of cutaneous malignancy by gammadelta T cells. from 2003 to 2006, covering the biotechnology and life-science tools sectors. J Hemotother 5(5):503-9 (1996).

Therapies

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

Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

Packaging

Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

Animal Testing

Agency IQ

OCTOBER 12, 2023

While this development, on its own, is noteworthy, the judiciary rationale behind the ruling will impact wider EU trends and serve as precedent for future chemical regulation. This regulation has since been repealed and replaced with Implementing Regulation (EU) 2020/1740 , though many of the provisions and their articles remain the same.

Regulations

Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

Packaging

Eye on FDA

JULY 7, 2020

Then as part of the agency’s effort at putting together a regulatory stance regarding the unique questions posed by the huge migration into digital and social communications, FDA later that year posed a series of five questions to inform the regulation of this burgeoning environment during a public meeting held that same year.

FDA

Broad Institute

AUGUST 2, 2023

Known to be a regulator of metabolism, we have found that in addition it has profound behavioral effects in animals and humans, even evident in population-level economic behavior. in Physics from Massachusetts Institute of Technology in 2009. With this proposal, we will add a measure of thyroid hormone, T3, to the assessment battery.

Medical Schools

Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

Clinical Trials

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

Pharmaceuticals

Advarra

FEBRUARY 22, 2024

regulations. In 2009, the Food and Drug Administration (FDA) released a  guidance document on AE reporting to IRBs. These responsibilities and reporting requirements are outlined in U.S.

Drugs

Agency IQ

AUGUST 11, 2023

Given this significance, it’s worth analyzing its chaotic regulatory history, examining the implications of the risk assessment document itself, and projecting how this controversial active substance is likely to be treated by EU regulators going forward. The EU adopted an amendment allowing for this on the same day the AGG was formed.

Regulations

Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

Regulations

New Drug Approvals

JANUARY 9, 2024

Nature Cell Biology, 11, 1275 – 1276, 2009), whilst different tumors appear to require some, but they are independent of other interphase CDKs (CDK2, CDK4 , CDK6). In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. 27, 6012-6018, 2009; Christian et al., 3, S179-S185, 2009).

Production

Vial

MAY 1, 2024

It also maintains strict compliance with regulatory guidelines like the US Food and Drug Administration’s 21 CFR Part 11 , HIPAA (Health Insurance Portability and Accountability Act), and GDPR (General Data Protection Regulation). Read more here about how Vial’s EDC system compares with that of industry giants.

Clinical Trials

Conversations in Drug Development Trends

FEBRUARY 22, 2023

I joined the FARA staff in 2009, and our team built a nationwide series of bike rides called rideATAXIA to raise funds for research. At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

Disease

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman Amendments—the statute that amended Title 35 of the United States Code to create PTEs for certain FDA-regulated products—and a recent spate of PTE-related items posted on regulations.gov, we thought we would peruse some decisions to see what’s up at (..)

FDA Approval

DrugBank

JUNE 27, 2023

14 As an unbiased method for genetic variant detection, GWAS holds the promise of identifying new genes and gene regulation mechanisms underlying a variety of conditions, including complex diseases. 5 , e1000433 (2009). PLoS Genet.  Kennedy, A. Ozbek, U. & & Dorak, M. What has GWAS done for HLA and disease associations?

Disease

Agency IQ

JANUARY 19, 2024

WALKER LIVINGSTON, ESQ | JAN 17, 2024 8:30 PM CST Background: Clean Air Act and NAAQS Under the Clean Air Act (CAA), the Environmental Protection Agency (EPA) must issue a cornucopia of air quality-related regulations to protect the environment and public health of the country. BY PATRICIA ISCARO, ESQ.,

Regulations

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

FDA

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

Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. The regulation also obliges sharing information on already registered chemicals and, whenever possible, reducing unnecessary duplication of testing.

Animal Testing

Drug Target Review

JUNE 29, 2023

It set a precedent with regulators as to what is expected in some instances. Prior to joining Adaptimmune in 2009, Jo held positions at Avidex, Medigene and Immunocore. Looking back, at the way we approach safety in preclinical testing and in IND (investigation new drug) submissions was really changed by those papers.

Therapies

Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Ecophyto II+ also incorporated European obligations under Directive (EC) 2009/128 on the sustainable use of pesticides (SUD) to adopt national action plans setting targets for pesticide reduction.

Government

Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 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.

Regulations

Broad Institute

JULY 28, 2023

Future work will then examine how to regulate the accelerated rate of PNN maturation in ELS females and what prevents this from occurring in ELS males. in Physics from the University of Illinois at Urbana-Champaign in 2009. in Physics from Massachusetts Institute of Technology in 2009. He received his Ph.D. earned his Ph.D.

Medical Schools

The Pharma Data

AUGUST 1, 2021

The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. 4 Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in regulating the inflammatory pathways implicated in SLE. 17,18 At least five million people worldwide have a form of lupus.

Trials