Agency IQ

MAY 31, 2024

Program Agency Deadline Survey: EU4Health Annual Work Program 2025 European Commission 6/10/2024 Survey: Real4Reg survey on real-world data Real4Reg/EMA 6/14/2024 Survey: EMA Communication perception EMA 6/21/2024 Survey: E.U. These include, but are not limited to, calls for applicants, expressions of interest and surveys.

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Regulations Production Compliance Pharmaceuticals 40

Agency IQ

OCTOBER 27, 2023

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Agency IQ

MAY 3, 2024

voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Expected Action Description of action Original Deadline Pharmaceuticals – changes to marketing authorisations (review of EU rules) [E.U.]

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

FDA Law Blog: Biosimilars

JUNE 7, 2023

to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value. First, Merck characterizes the program as a “ per se taking” without just compensation under the Fifth Amendment, because manufacturers are “force[d]. Complaint at 2.

Government 44

Government Compliance Drugs Production 44

Agency IQ

JULY 8, 2024

and the E.C.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. centralized procedure until 2025, when the Windsor Framework takes effect.

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International Regulations Production Marketing 40

The Pharma Data

FEBRUARY 8, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% price, patients switching to Toujeo ® and biosimilar glargine competition. Pharmaceuticals business operating income. Specialty Care.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% price, patients switching to Toujeo ® and biosimilar glargine competition. Pharmaceuticals business operating income. Specialty Care.

Vaccine 52

Vaccine Production FDA Therapies 52

The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. In April 2021, Pfizer announced that it has acquired Amplyx Pharmaceuticals, Inc. CAPITAL ALLOCATION.

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Vaccine Production FDA Clinical Trials 40