Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Drug Channels

JULY 29, 2020

Cool off by getting up close and personal with our refreshing selection of articles and insights. We are offering our 2019–20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors at discounts up to 35% off. The steamy, socially distanced days of summer are here.

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Pharmacy Biosimilars Drugs Pharmaceuticals 52

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. In the proposed revision to the European pharmaceutical legislation, both the regulation and directive introduce two very similar though distinct concepts: unmet medical need, and high unmet medical need.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

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.

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Regulations Biosimilars Clinical Trials Production 40

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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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

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Now it is up to the Council to provide their position.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 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.

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Regulations Production Clinical Trials Biosimilars 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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

MAY 31, 2024

.: Hands-on training course Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/03/2024 EUCOPE’s Life Science Lectures – Episode Five (Joint Clinical Assessments) Webinar/Seminar ( OPEN ) EUCOPE 6/04/2024 6/04/2024 EUDAMED, the pathway to compliance Webinar/Seminar ( OPEN ) Team Person Responsible for Regulatory Compliance (TEAM-PPRC) 6/04/2024 6/04/2024 News (..)

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

DECEMBER 1, 2023

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

SEPTEMBER 22, 2023

patient, caregiver) in the use of their medications (including both pharmaceuticals and biological products) would be considered PDURS. Similarly, the agency simply notes that it would review potential biosimilar or interchangeable products consistent with its existing regulatory expectations for licensure.

FDA 40

FDA Biosimilars Production Drugs 40

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52

FDA Biosimilars Science Production 52

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement. The facts are detailed in the complaint.

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Production FDA Licensing Licensing 59

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This article provides a comparative overview of Vial and IQVIA.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 28, 2023 12:13 AM EDT Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., including direct-to-consumer advertising.

FDA 40

FDA Drugs Regulations Production 40

FDA Law Blog: Biosimilars

JANUARY 3, 2024

With the growth in pet ownership, the pet health product market has also exploded; a Bloomberg article from March 2023 noting that the growth in the pet industry market “is driven by an increase in spending on pet-related healthcare—including veterinary care, diagnostics, and pharmaceuticals—that has created longer pet lifespans that require more expensive (..)

Drugs 59

Drugs FDA Licensing Licensing 59

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). By geographical region, the global CRO services market in 2023 was dominated by North America. By revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., with full-year revenue of US$23.04 of total revenue).

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Agency IQ

AUGUST 2, 2024

and the E.C.

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FDA Science Regulations Biosimilars 40

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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FDA Science Regulations Production 40

Agency IQ

JULY 8, 2024

and the E.C.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

and the E.C.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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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

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. from the E.U. on February 1, 2020 started a year-long transition period; The E.U.

International 40

International Regulations Production Marketing 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 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

DECEMBER 1, 2023

The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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FDA Science Regulations Production 40

The Pharma Data

AUGUST 21, 2020

In non-COVID-19 news, Amazon has entered the pharmaceutical market by launching ‘Amazon Pharmacy’ in India, while Johnson & Johnson is set to buy the Cambridge-based Momenta Pharmaceuticals for $6.5 billion, making it the largest pharmaceutical industry deal this year so far. Amazon Pharmacy launches in India.

Biosimilars 52

Biosimilars Pharmacy Vaccine Pharmaceuticals 52

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., for multiple violations observed during an inspection that occurred eight months ago.

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FDA Regulations Pharmaceuticals Drugs 113

FDA Law Blog: Biosimilars

DECEMBER 3, 2024

142, the Preserve Access to Affordable Generics and Biosimilars Act. Nevertheless, we are where we are at the moment and Congress is pressing on for passage of the Preserve Access to Affordable Generics and Biosimilars Act. Karst — On August 30, 2024, we posted on what was then the most recent version of S.

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Biosimilars Licensing Licensing Production 80

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

Kennedy stated that payment of these user fees by industry “creates a barrier to entry to smaller firms and puts bureaucrats’ purse strings in the hands of the pharmaceutical industry.” Kennedy does not say what the alternative to user fees would be given current budget realities.

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