Biosimilars, Drugs, Vaccine and Webinar

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. ’s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations

Regulations Pharmaceuticals Production Compliance

Article EMA Thank You What we expect European regulators to do in March 2024

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations

Regulations Biosimilars Clinical Trials Production

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science

Science Biosimilars FDA Production

Article EMA Thank You What we expect European regulators to do in December 2023

Agency IQ

DECEMBER 1, 2023

The European Commission also plans to create a Critical Medicines Alliance for a more coordinated effort in managing drug shortages within the E.U. We are expecting to see the release of an E.U. This effort will most likely be set up in early Q1 of 2024.

Regulations

Regulations Clinical Trials Production Biosimilars

Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

MARCH 29, 2024

This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

Regulations

Regulations Production Biosimilars Clinical Trials

Article EMA Thank You What we expect European regulators to do in June 2024

Agency IQ

MAY 31, 2024

Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries. s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations

Regulations Production Compliance Pharmaceuticals

Article EMA Thank You What we expect European regulators to do in November 2023

Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Regulations

Regulations Pharmaceuticals Production Packaging

Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Major European regulators, national competent authorities, and interest groups are planning on hosting several webinars and trainings throughout August and September. Speaking of policy, legislative affairs will also likely pick up.

Regulations

Regulations Clinical Trials Production International

Six Crucial Trends Facing U.S. Drug Wholesalers

Drug Channels

DECEMBER 1, 2020

If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. distribution channels for prescription drugs. They are now poised to play a vital role in distributing COVID-19 vaccines and therapeutics as they become available. drug wholesaling industry. d/b/a Drug Channels Institute.

Pharmacy

Pharmacy Vaccine Drugs Pharmaceuticals

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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.

FDA

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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.

FDA

FDA Science Regulations Production

Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Article EMA Thank You What we expect European regulators to do in July 2024

Trending Sources

Article EMA Thank You What we expect European regulators to do in March 2024

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Article EMA Thank You What we expect European regulators to do in December 2023

Article EMA Thank You What we expect European regulators to do in April 2024

Article EMA Thank You What we expect European regulators to do in June 2024

Article EMA Thank You What we expect European regulators to do in November 2023

Article EMA Thank You What we expect European regulators to do in August and September 2024

Six Crucial Trends Facing U.S. Drug Wholesalers

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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