2024, Licensing and Packaging - Drug Discovery Digest

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

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We’re about to find out.

FDA

FDA Science Regulations Production

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

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Biosimilars

Early-stage biotech investment: where are we?

Drug Discovery World

JUNE 17, 2024

The money is there but investors are being more selective about who they back. Fortunately, just like the weather, it looks as if things are looking up for the sector as we go into the second half of 2024. The response to this type of advice is usually ‘we don’t have the money to pay those salaries!’

Packaging

Packaging Science Marketing International

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

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Clinical Trials

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. July 31, 2024. [ii] 89 FR 61474.

Pharmacokinetics

Pharmacokinetics FDA Production Drugs

Nine Key Takeaways from Dreamforce 2023

Perficient: Drug Development

SEPTEMBER 19, 2023

Increased Capabilities for Marketing Cloud and Commerce Cloud Salesforce introduced 26 generative AI capabilities between Marketing Cloud and Commerce Cloud, 14 of which are in GA now, with an additional 14 to arrive by the end of 2024.

Licensing

Licensing Licensing Production Marketing

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

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. But because the statute sets FIE expiration at the earlier of the relevant conditions, the April 15, 2023 and September 28, 2023 dates were the FIE expiration dates.

Biosimilars

Biosimilars FDA Production Packaging

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

Agency IQ

JANUARY 19, 2024

BY KIRSTEN MESSMER, PHD, RAC | JAN 17, 2024 9:16 PM CST Quick background: EMA annual new medicines reports At the beginning of each calendar year, the EMA publishes a New Medicines Highlights report, providing a high-level overview of new medicines reviewed by the EMA’s Committee for Medicinal Products of Human Use (CHMP). Based on the E.U.

Biosimilars

Biosimilars FDA Production Treatment

Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

FDA

FDA Drugs Production Licensing

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database.

Clinical Trials

Clinical Trials Trials Science FDA

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. wide license: The requirements of the E.U.

Packaging

Packaging Licensing Licensing Regulations

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date. When such a situation is identified, it is noted in the product labeling.

Science

Science FDA Packaging Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Some of the affected former NDAs were approved using drug master files (DMFs).

Regulations

Regulations FDA Science Production

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

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Asimov Press (2024). There is also a growing body of successful treatments in the U.S., Scaling Phage Therapy."

Therapies

Therapies DNA Virus Clinical Trials

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

Agency IQ

JANUARY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JAN 5, 2024 4:59 PM CST Regulatory Background and Context Under 21 USC 384, also known as Section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act), HHS has the authority to issue regulations allowing wholesale drug importation.

FDA Approval

FDA Approval FDA Science Drugs

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

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

Regulations

Regulations FDA Science Production

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. EPA’s FIP was due January 7, 2021. Comite Progreso de Lamont v. Cal, 21-cv-08733).

Regulations

Regulations Compliance Production Science

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

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA

FDA Science Biosimilars Regulations

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. 122 (2023), are beginning to percolate through the Pennsylvania courts, and may see appellate action as soon as late 2024. See you in 2024.

Testimonials

Testimonials FDA Drugs Vaccine

PREP Act Immunity: Baghikian v. Providence Health & Servs.

Drug & Device Law

FEBRUARY 29, 2024

3d __, 2024 U.S. LEXIS 22420, 2024 WL 487769 (C.D. 2:23-cv-2853 WBS DB, 2024 U.S. 21, 2024)). The PREP Act has captured our attention before, but recently, in Baghikian v. Providence Health & Services , No. CV 23-9082-JFW(JPRX), __ F.Supp.3d 247d-6d(a)(2)(B). Baghikian already has been followed in Fust v.

Government

Government Production Packaging FDA

Preemption as a Backup for the Learned Intermediary Rule

Drug & Device Law

FEBRUARY 19, 2024

That regulation provides that a prescription-only drug – one that can only be obtained through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’” – is “exempt” from requirements to provide adequate directions for use to patients. 2024 WL 477523, at *3 (Mag. 201.100(a-b).

Licensing

Licensing Licensing Regulations FDA

Drug Discovery Digest

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

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

Trending Sources

Early-stage biotech investment: where are we?

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

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

Nine Key Takeaways from Dreamforce 2023

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

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

Article FDA Thank You CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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

Scaling Phage Therapy

Analysis Life Sciences Thank You After lengthy review, FDA approves Florida’s drug importation plan

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

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

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

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

PREP Act Immunity: Baghikian v. Providence Health & Servs.

Preemption as a Backup for the Learned Intermediary Rule

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