2024, Compliance and Licensing - Drug Discovery Digest

“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices

FDA Law Blog: Biosimilars

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

Pharmaceuticals

Pharmaceuticals Licensing Licensing Compliance

NYSDFS Part 500 Cyber Amendments Finalized: What You Need to Know

Perficient: Drug Development

FEBRUARY 15, 2024

The NYSDFS Part 500 amendments signal a crucial shift in the financial services regulatory landscape and underscore the importance of robust governance, risk management, and compliance frameworks. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

Compliance

Compliance Regulations Licensing Licensing

DFS500 Amendments: What You Need to Know

Perficient: Drug Development

FEBRUARY 15, 2024

These DFS500 amendments signal a crucial shift in the regulatory landscape, emphasizing the imperative for robust governance, risk management, and compliance frameworks across the financial industry. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

Compliance

Compliance Licensing Licensing Regulations

7 Reasons Why 2024 Will be the Year of XM Cloud

Perficient: Drug Development

JANUARY 3, 2024

As we enter 2024, most of the conversations we have are focused on XM Cloud. Even if the hosting and licensing costs are close, the operational costs of managing a true SaaS offering vs. what you need to support PaaS makes it even more compelling. But XM Cloud will continue to be the main focus and growth driver in 2024.

Compliance

Compliance Marketing Production Licensing

Healthcare, HIPAA, Sitecore and BAAs

Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. This is because under the covers it is actually using the same instance.

Licensing

Licensing Licensing Production Regulations

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

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. However, labeling requirements depend on the type of license of the medicine. license number.

Packaging

Packaging Licensing Licensing Regulations

Article EMA Thank You New roadmap sets out U.K. device regulation timelines

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K. both pre- and post-market.

Regulations

Regulations Government Compliance Marketing

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA’s February 23, 2024 decision says that “the grounds for withdrawing approval have been met because: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. . §

FDA

FDA Production FDA Approval Licensing

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

FDA

FDA Production Marketing Drugs

Article EMA Thank You Swissmedic reorg adds new focus on medical device market surveillance

Agency IQ

JANUARY 4, 2024

BY COREY JASEPH, MS, RAC | JAN 3, 2024 9:15 PM CST Quick background on the medical device regulatory picture in Switzerland Switzerland follows E.U. The reorganization separates device surveillance from medicinal product surveillance , which is divided into two sectors – licensing and surveillance, and product authorization and vigilance.

Marketing

Marketing Regulations Clinical Trials International

Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

FDA Law Blog: Biosimilars

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). Factor B was the pharmacy’s experience with dispensing or conducting research with respect to controlled substances while Factor D was compliance with applicable state, federal, or local laws relating to controlled substances. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 823(g)(1).

Pharmacy

Pharmacy Drugs Regulations Licensing

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

Article FDA Thank You Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions

Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

FDA

FDA Laboratories Regulations Clinical Trials

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

Agency IQ

JUNE 29, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. OIG claims a review will be complete in 2024. Comments on the proposal closed on July 19.

FDA

FDA Science Regulations Production

Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Agency IQ

SEPTEMBER 1, 2023

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. Medicines developers can apply through the new framework beginning January 1, 2024. market more quickly.

International

International Regulations Production Marketing

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

MARCH 25, 2024

BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy. What is drug compounding?

FDA

FDA Pharmacy Drugs Production

Analysis Life Sciences Thank You E&C lawmakers grill directors of FDA medical product centers

Agency IQ

MAY 28, 2024

BY RACHEL COE, MSC | MAY 23, 2024 7:12 PM CDT Yesterday’s Energy & Commerce Health Subcommittee Hearing All three of FDA’s medical product center directors appeared before the Health Subcommittee of the U.S. If you don’t have the staff to do this, how are you going to have the staff to do that?”

FDA

FDA Production Science Clinical Trials

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Compliance

Compliance Drugs Pharmacy Licensing

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

FDA

FDA Science Biosimilars Clinical Trials

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 A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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

DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog: Biosimilars

MAY 5, 2024

OASH concluded “there is widespread current experience with medical use in the United States” by licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine in these states.” Congress has enacted a number of CSA provisions to ensure compliance. 21 U.S.C. § 21 U.S.C. §

FDA

FDA Regulations Treatment Licensing

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

Agency IQ

JUNE 2, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. OIG claims a review will be complete in 2024. Comments on the proposal closed on July 19.

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

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 What life sciences companies need to know about NIST’s new AI guidance

Agency IQ

MAY 10, 2024

BY LAURA DIANGELO, MPH | MAY 8, 2024 8:17 PM CDT FDA, NIST and their work on artificial intelligence (AI): The National Institute of Standards and Technology (NIST) is part of the U.S. GAI systems may infringe on copyrighted or trademarked content, trade secrets, or other licensed content,” which are “often” part of the training data sets.

Science

Science FDA Production Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 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 Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) 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 Clinical Trials Regulations

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

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November. Review to take place within 21 days.

FDA

FDA Science Regulations 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

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.

Regulations

Regulations Compliance Production Science

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

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

Drug & Device Law

DECEMBER 29, 2023

Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether.

Testimonials

Testimonials Drugs FDA Vaccine

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog: Biosimilars

OCTOBER 14, 2024

Gonzalez — On September 27, 2024, in U.S. Facts Defendants in this case are two licensed physicians and the stem cell clinics they founded. By Steven J. California Stem Cell Treatment Center, Inc., Defendants may also seek en banc review of the decision from the full Ninth Circuit.

Regulations

Regulations Treatment FDA Licensing

Navigating the AI revolution: a roadmap for pharma’s future

Drug Target Review

MARCH 13, 2025

The operational impact of xAI is substantial, especially given that 37 percent of the market views the explanation of results from GenAI algorithms as a strategic priority that goes beyond regulatory compliance. 2024 [cited 2025 Feb 7]. 2024 [cited 2025 Feb 7]. 2024 [cited 2025 Feb 7]. 2024 [cited 2025 Feb 7].

Drug Development

Drug Development Clinical Trials Science Drugs

Drug Discovery Digest

“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices

NYSDFS Part 500 Cyber Amendments Finalized: What You Need to Know

Trending Sources

DFS500 Amendments: What You Need to Know

7 Reasons Why 2024 Will be the Year of XM Cloud

Healthcare, HIPAA, Sitecore and BAAs

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

Article EMA Thank You New roadmap sets out U.K. device regulation timelines

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

Article EMA Thank You Swissmedic reorg adds new focus on medical device market surveillance

Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

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

Article FDA Thank You Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions

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

Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Analysis Life Sciences Thank You E&C lawmakers grill directors of FDA medical product centers

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

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

DEA Concurs: Marijuana Meets Schedule III Criteria

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 November 2023

Analysis Life Sciences Thank You What life sciences companies need to know about NIST’s new AI guidance

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

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

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

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

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

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

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

Navigating the AI revolution: a roadmap for pharma’s future

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