2023, Biosimilars, Packaging and Pharmaceuticals

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog: Biosimilars

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”).

Biosimilars

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

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

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Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

Biosimilars

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European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Clinical Trials

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

FDA

FDA Science Regulations Production

Animals Need Drugs Too, But Not Without CVM Approval

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

Drugs

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA

FDA Science Regulations Biosimilars

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

Agency IQ

AUGUST 2, 2024

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes | Oct 25, 2023 5:20 PM CDT | Updated Jul 31, 2024 10:17 PM CDT What we expect to be talking about in August and September Based on our scanning, AgencyIQ expects that August will be another sleepy summer month for European regulators.

Regulations

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

Agency IQ

MAY 31, 2024

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES , CHELSEY MCINTYRE, PHARMD | OCT 25, 2023 5:20 PM CDT | UPDATED MAY 30, 2024 12:16 PM CDT What we expect to be talking about in June Regulators of all sizes – from the EMA to national competent authorities – will be busy with meetings in June.

Regulations

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

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA

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FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. 355(j)(2)(A)(v). .

FDA

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Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. CDER approved 51 new molecular entities in FY 2023.

FDA

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

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

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

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

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

Agency IQ

MAY 3, 2024

BY CHELSEY MCINTYRE, PHARMD , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES , SEBASTIAN GODOY, MPH | OCT 25, 2023 5:20 PM CDT | UPDATED APR 30, 2024 12:57 PM CDT What we expect to be talking about in May: Regulators, especially from the EMA and national competent authorities, will be busy with lots of meetings in May.

Regulations

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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

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

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

FDA

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Drug Discovery Digest

Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

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

Trending Sources

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

European Commission vs Big Pharma, or profit vs access?

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Animals Need Drugs Too, But Not Without CVM Approval

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

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

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

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

FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

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

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

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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