FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. By Jeffrey N.

FDA 111

FDA Production Trials Pharmacy 111

FDA Law Blog: Biosimilars

NOVEMBER 22, 2023

FDA subsequently established an interim food additive regulation, codified at 21 C.F.R. §  180.30 , which authorizes the use of BVO as a stabilizer for flavoring oils in an amount not to exceed 15 ppm in the finished fruit-flavored beverage. In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

FDA 52

FDA Regulations Production 52

The Premier Consulting Blog

NOVEMBER 20, 2023

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Laboratories 52

Laboratories FDA Clinical Development Regulations 52

FDA Law Blog: Biosimilars

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

FDA 52

FDA Regulations Clinical Trials Production 52

Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

Production 40

Production Regulations Compliance Packaging 40

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 40

Animal Testing Regulations Production Research 40

Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 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 Government Production 40

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 Regulations Research 40

The Pharma Data

JUNE 7, 2022

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2027, except upon the occurrence of an early release event provided for under Article R. The voting rights attached to the subscribed Shares will be exercised directly by the employees.

Regulations 40

Regulations Vaccine Science Treatment 40

Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Packaging 40

Packaging Regulations Production Compliance 40

Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

Pharmaceuticals 40

Pharmaceuticals Regulations Production Packaging 40

FDA Law Blog: Biosimilars

AUGUST 23, 2023

By Adrienne R.

Production 52

Production Clinical Trials FDA Drugs 52

The Pharma Data

JANUARY 26, 2021

billion by 2027. . With very limited approved first-line pharmaceutical therapies for HCC available today, challenges include drug resistance, adverse side effects, and high costs. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9

FDA 40

FDA Treatment Small Molecule Government 40

The Pharma Data

DECEMBER 14, 2020

Market researchers expect the global market for gene and cell therapy to grow at a CAGR of over 25% through 2027. c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. The kit can be used to detect DENARASE residues. About c-LEcta.

Vaccine 52

Vaccine Production Engineering Therapies 52

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 40

Regulations Compliance International Engineering 40

Agency IQ

SEPTEMBER 6, 2023

A warning letter represents the FDA’s determination that a manufacturer has “ significantly violated ” FDA regulations, including those related to current good manufacturing practices (CGMPs). In FY2025, that will increase to a goal of 70%, and in FY2026-2027, it will increase to 80%.

FDA 40

FDA Packaging Drugs Pharmaceuticals 40

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. However, a producer may also choose to apply for independent compliance with the requirements.

Regulations 40

Regulations Packaging Compliance Production 40

Drug Discovery World

JULY 17, 2024

NK: IO builds on the discovery in Brady’s lab of E4BP4 as a central transcriptional regulator of NK cell development, with REV-ERB and Notch receptor as key control points. Small molecule inhibition of REV-ERB stimulates E4BP4 expression, synergistically with the effects of notch ligands, greatly enhancing NK cell production and function.

Therapies 130

Therapies Engineering Small Molecule Clinical Development 130

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

Laboratories 64

Laboratories FDA Regulations Compliance 64

Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. In-house tests (in the U.S.

Regulations 40

Regulations Compliance Laboratories Production 40

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 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

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

Science 40

Science Regulations Laboratories Production 40

Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. By contrast, a biosimilar product is only “highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency.”

Science 40

Science Biosimilars FDA Production 40

FDA Law Blog: Biosimilars

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027). up to 125 total products enrolled through FY 2025).

Production 45

Production FDA Clinical Trials Marketing 45

Agency IQ

SEPTEMBER 15, 2023

The SCP Regulations define a candidate chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is found on one or more of the authoritative lists specified in section 69502.2(A) A) , or listed by DTSC using the criteria specified in section 69502.2(B). Chapter 54.

Regulations 40

Regulations Packaging Production Government 40

FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

FDA 59

FDA Regulations Production Drugs 59

Agency IQ

NOVEMBER 3, 2023

BY LAURA DIANGELO, MPH | OCT 30, 2023 9:38 PM CDT FDA’s new proposed rule on the regulation of laboratory developed tests An incredibly quick background : Laboratory developed tests (LDTs) are considered a subset of in vitro diagnostics (IVDs). IVDs are regulated as medical devices in the U.S., Quick intro: QSR, QMSR.

FDA 40

FDA Laboratories Regulations Production 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.

Regulations 40

Regulations Production Compliance Science 40

The Premier Consulting Blog

APRIL 27, 2023

Technical Conformance Guide HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 How can you prepare? Author: Yasmin Rodino Regulatory Operations Associate Learn more about eCTD v4.0: ICH electronic Common Technical Document – eCTD v4.0 Support Documentation for M8: eCTD EWG eCTD v4.0 Implementation Package v1.5

Packaging 52

Packaging FDA International Pharmaceuticals 52

Agency IQ

APRIL 8, 2024

Enforceable regulations on PFAS in drinking water are expected soon [see this AgencyIQ analysis for more information] ; municipalities are likely looking to have a settlement in hand now, rather than waiting for an uncertain future payout, to ensure that they can fund the means to provide safe drinking water around the country.

Government 40

Government Regulations Trials Production 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary). primary and secondary).

FDA 40

FDA Science Biosimilars Production 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

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 40

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

FDA 40

FDA Regulations Laboratories Production 40

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. In February 2021, Pfizer announced that the U.S. Patent and Trade Office issued a U.S. Patent Term Extension certificate extending the term of U.S.

Vaccine 40

Vaccine Production FDA Biosimilars 40

Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

FDA 40

FDA Science Biosimilars Regulations 40