FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

(HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, in San Francisco, California.

FDA

FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

Compliance

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

Drug Channels

JUNE 5, 2023

Join peers this August to discover the evolving specialty pharmacy marketplace, build multi-stakeholder partnerships, and explore frameworks to inform your 2024 distribution and patient service strategies.

Specialty Pharmacies

FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. AbbVie), for a direct-to-consumer (DTC) TV advertisement for its drug UBRELVY (ubrogepant) that features tennis star, social media influencer and entrepreneur Serena Williams.

Clinical Trials

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this 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. and national regulators.

Regulations

FDA Law Blog: Biosimilars

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms. Before joining HP&M, Ms.

Compliance

FDA Law Blog: Biosimilars

JANUARY 8, 2024

Claud — As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. We won’t repeat ourselves, but we will summarize—regulatory due diligence and an understanding of historical regulatory compliance issues is a critical component of assessing whether a deal is what it seems to be. By John W.M.

FDA

FDA Law Blog: Biosimilars

OCTOBER 8, 2023

That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. DEA also announced that it is working to promulgate these new telemedicine standards or safeguards by the fall of 2024. 69,879, 69,880 (Oct.

Compliance

FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

Government

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485. By Steven J. Gonzalez & Lisa M. SCF : LDT, unmet need within an integrated healthcare system. 21 CFR 820.20

FDA

FDA Law Blog: Biosimilars

MARCH 29, 2024

Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022. In December, Commissioner Robert Califf wrote about the importance of transparency in trials , noting the FDA takes a risk-based approach to compliance and enforcement. The vast majority are for drugs.

Clinical Research

Conversations in Drug Development Trends

JULY 9, 2024

Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies. Glucagon also spares the GLP-1 effects potentially reducing side effects leading to increased compliance.

Clinical Research

FDA Law Blog: Biosimilars

JULY 8, 2025

The Agency confirmed that it will now accept progress reports in lieu of full compliance by August 1, 2025, and has explicitly asked sponsors to detail their mitigation efforts in their upcoming annual or amended annual reports. What does this mean? 2023); FDA, Guidance, Control of Nitrosamine Impurities in Human Drugs at 12 (Sept.

FDA

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Under the proposed rule, if held articles are not brought into compliance within 10 days (if held because prior notice was missing) or within 30 days (if held because food facility registration was missing), they may only be sold for export or destroyed, unless otherwise agreed to by FDA and CBP.

Regulations

FDA Law Blog: Biosimilars

MARCH 24, 2024

On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. 22-3675, 2024 U.S. 2024) at 13 (“Decision”). PhRMA alleges no circumstances where a covered entity’s contract pharmacy arrangement has made simultaneous compliance with state and federal law impossible.” & Mfrs. McClain , No. LEXIS 5840 (8th Cir.

Pharmacy

FDA Law Blog: Biosimilars

JULY 31, 2025

For decades, FDA largely ignored this $6 billion industry through a 1988 compliance policy guide (CPG) that essentially created a regulatory “safe harbor” for over-the-counter homeopathic products. That said, enforcement actions against these unapproved drugs are generally based on safety considerations.

FDA

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. FDA intends to finalize the guidance on Advanced Manufacturing Technologies Designation program by the end of 2024.

FDA

FDA Law Blog: Biosimilars

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

FDA

FDA Law Blog: Biosimilars

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.

FDA

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Speaking of which, given the statements FDA has made to date, we fully expect FDA to issue a final rule; while we cannot predict when, one press report predicted it could happen as soon as May 2024.

Laboratories

FDA Law Blog: Biosimilars

MAY 10, 2023

In addition, concerning any practitioner-patient telemedicine relationships that have been or will be established up to November 11, 2023, all telemedicine flexibilities concerning prescribing of controlled substances established during the COVID-19 PHE will also be extended for one year – through November 11, 2024. 30,038 (May 10, 2023).

Compliance

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA encourages parties to require compliance with such requirements through contractual agreements between manufacturers.

FDA

FDA Law Blog: Biosimilars

NOVEMBER 20, 2023

The changes at OPQ will take effect on January 14, 2024. We’ll almost certainly hear more about this as the Agency cements its organizational changes in 2024. Cavazzoni told staff that the changes at OPQ will strengthen “connections between assessment, inspection, surveillance, research, policy, and administrative operations.”

Pharmaceuticals

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

However, meeting this timeline would require FDA to issue a final rule within approximately six months of the PR’s publication date—in other words, by April 2024. This timing undermines the Agency’s rationale that three years is enough time to come into compliance.

Laboratories

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 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

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. not discontinued) and are available for sale.

FDA

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.

International

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

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

FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Both are celebrating their 75th anniversaries in 2024. 2024 brings a host of Hyman, Phelps & McNamara, P.C. 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”) In other exciting news — in 2024 FDLI will be getting a make-over! What do Gene Autry’s Rudolph the Red-Nosed Reindeer and FDLI have in common?

Compliance

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

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this 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. and national regulators.

Regulations

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

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this 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. and national regulators.

Regulations

FDA Law Blog: Biosimilars

JUNE 30, 2024

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape.

FDA