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 40

FDA Science Regulations Production 40

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 57

Pharmaceuticals Compliance Licensing Licensing 57

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 40

FDA Science Regulations Clinical Trials 40

FDA Law Blog: Biosimilars

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional. FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

FDA 109

FDA Regulations Treatment Licensing 109

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. By Karla L. The federal telemedicine flexibilities (i.e.,

FDA Approval 52

FDA Approval Regulations Pharmacy Licensing 52

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 40

Biosimilars FDA Production Treatment 40

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 57

Regulations Treatment FDA Licensing 57

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

On 28 August, 2024, almost a year after FDA’s interim response to the CP, NPA filed a complaint in US District Court for the District of Columbia seeking preliminary and permanent injunction prohibiting FDA from taking any regulatory action against firms producing or marketing NMN.

Production 57

Production FDA Licensing Licensing 57

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 104

Compliance Drugs Pharmacy Licensing 104

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 57

FDA Production FDA Approval Compliance 57

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., OIG claims a review will be complete in 2024. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

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 57

FDA Production Marketing Drugs 57

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.

FDA 40

FDA Science Regulations Production 40

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. We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Clinical Trials 40

FDA Law Blog: Biosimilars

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 823(g)(1). at § 64B16-27.800(2).

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

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].

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. DEA found in 2016 that marijuana met none of the of elements and therefore did not have a currently accepted medical use in treatment in the U.S.

FDA 67

FDA FDA Approval Treatment Drugs 67

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., OIG claims a review will be complete in 2024. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

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 40

FDA Science Regulations Production 40

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

Production 52

Production Clinical Trials International Small Molecule 52

FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. §

Regulations 67

Regulations FDA Treatment Drugs 67

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 40

FDA Science Regulations Production 40

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. billion due to recent and expected generic and biosimilar competition for certain products that have recently lost or are anticipated to soon lose patent protection.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Agency IQ

SEPTEMBER 1, 2023

Medicines developers can apply through the new framework beginning January 1, 2024. The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” market more quickly.

International 40

International Regulations Production Marketing 40

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. That would leave 19% of staff affected by furloughs.

FDA 40

FDA Science Biosimilars Regulations 40

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.” Three Republican senators on the Foreign Relations Committee advised to consider U.S. 21 U.S.C. §

FDA 94

FDA Regulations Treatment Licensing 94

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Rescheduling would eliminate a tax burden on cannabis companies, allowing licensed companies to expand investments into state programs and focus on public health in collaboration with law enforcement efforts. January 29, 2024). Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

Regulations 57

Regulations Production FDA Approval Drugs 57