FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. 11] Jeffrey N.

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Agency IQ

MAY 3, 2024

A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect.

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DrugBank

MARCH 15, 2023

The moment you decide which DrugBank license or products best suit your needs isn’t the final step in our relationship, it is just the beginning. Depending on your unique needs, license*, and project goals, you might interact with all of them firsthand, or you might be off and running with just a little help from one team.

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Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Can you ship a drug from another country to the U.S. A: Yes, the EUA is just temporary.

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Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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The Pharma Data

DECEMBER 15, 2020

Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. KOL Webinar Information BioLineRx will host a KOL webinar today, December 16, 2020 at 8:00 a.m. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. MHRA also offered an online webinar to learn more about the pathway and public involvement.

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Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

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The Pharma Data

DECEMBER 12, 2020

5% have US Food and Drug Administration -approved treatments. Webinar and conference call. A webinar and conference call for investors and analysts will begin at 2:00 pm UK time today, please join 10-15 minutes prior to the scheduled start time. Webinar ID: 995 4603 8702. UK : +44 203 481 5237. Sweden : +46 8 5052 0017.

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Agency IQ

AUGUST 2, 2024

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

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Agency IQ

JANUARY 12, 2024

The regulator is also working on an Innovative Device Access Pathway (IDAP) that mirrors the pathway already in place for drugs (the Innovative Licensing Access Pathway, or ILAP). Canada, Japan, Brazil and Australia. Read AgencyIQ’s complete history and analysis of the lead-up to the proposed medical device regulations here.]

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Agency IQ

JUNE 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” Food and Drug Administration, the EMA and competent authorities of Member States. market more quickly.

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Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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Agency IQ

MARCH 1, 2024

On March 26, the Supreme Court will hear the case of Alliance for Hippocratic Medicine vs. FDA , a case which calls into question FDA’s authority to make regulatory changes, to be free from unreasonable scrutiny, and to ensure that the abortion drug mifepristone remains both approved and widely available.

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Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Drug Channels

MARCH 18, 2025

I am pleased to announce that Drug Channels Institutes new 2025 Economic Report on U.S. Download a free 30-page report overview including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits Read the press release: HMP Globals Drug Channels Institute Releases 2025 Economic Report on U.S.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2024

Indeed, in a recent Federalist Society-sponsored webinar, titled “ Does Jarkesy Doom the Preserve Access to Affordable Generics and Biosimilars Act? ,” moderator Brian Pandya (Duane Morris LLP) hashes out the interplay between Jarkesy and The Preserve Access to Affordable Generics and Biosimilars Act with Matthew S.

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Drug & Device Law

JANUARY 21, 2024

EST. The webinar will provide further insight and analysis on the cases featured in our posts on the worst decisions and best decisions of the past year. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed.

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Drug & Device Law

JANUARY 6, 2024

As we do each year, we’re pleased to announce that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2023” on Thursday, January 25th at 12 p.m.

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Drug & Device Law

NOVEMBER 4, 2023

Next up is Bexis , who, along with our colleague Jenn Eppensteiner , will present “ Preemption in Perspective: A Balanced Review of Preemption Issues Affecting Drugs, Medical Devices, and Vaccines as 2023 Draws to a Close.” All other webinars are presumptively approved for 1.0 All other webinars are presumptively approved for 1.0

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Drug & Device Law

JANUARY 7, 2023

As we do each year, we’re pleased to announce that three of your bloggers – Bexis, Steven Boranian, and Rachel Weil – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2022” on Thursday, January 19 th at 1 p.m.

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Drug & Device Law

NOVEMBER 5, 2022

You can register for the webinars here.). You can register for any of the webinars by clicking here. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Each remaining webinar is presumptively approved for 1.0

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Drug & Device Law

JANUARY 15, 2022

2021 has come to a close, and our loyal readers joined us as we reviewed the best and worst drug/medical device decisions of the year. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed.

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