FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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FDA Law Blog: Biosimilars

SEPTEMBER 12, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. These classifications usually result from observations listed on the FDA investigator’s report (a Form 483). By Adrienne R. Fifteen business days go by quickly! So, what makes for a strong response?

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Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). It authorized FDA oversight over mammography facilities.

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Drug Channels

DECEMBER 17, 2020

Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As you will see below, Dr. Gottlieb was right.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. But, as we detail in the WLF publication: “ the MDA supplies no such clear [congressional authorization].

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FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R. food supply and other food-related emergencies.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! Join our co-chairs Kurt R.

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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.

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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.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Author Information William E.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. While at FDA, Ms. During her FDA tenure, Ms. It was a true honor and privilege to collaborate with so many fantastic coworkers and partners for nearly 14 incredible years at FDA.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Assessing risks in regulated industry requires the appropriate depth and breadth of regulatory expertise. Deals in FDA regulated space are among the most complicated of any industry, and diligence adds cost.

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FDA Law Blog: Biosimilars

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic. By Allyson B. Mullen & Jeffrey N.

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FDA Law Blog: Biosimilars

JULY 2, 2024

Notwithstanding Justice Jackson’s partial dissent, it really seems like FDA now faces a new -yet- old standard for obtaining an injunction. FDA has a history of relying on the weight that courts give to the public health function of the FDCA to bring injunction suits under Section 332. With Starbucks , t hat looks to be ending.

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FDA Law Blog: Biosimilars

MAY 3, 2023

Livornese — FDA posted the last five “deemed final orders” under OTC monograph reform this week. All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA. the regulations formerly found in 21 C.F.R. By Deborah L. parts 331 through 358) were deemed to be final administrative orders as of the CARES Act effective date.

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FDA Law Blog: Biosimilars

OCTOBER 26, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — In our June blog post , we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. 552), there are exemptions from mandatory disclosure.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

FDA once estimated that OTC hearing aids would save patients over $3000.) The category of OTC hearing aids was created by congressional mandate and implemented by FDA to address an “unmet public health need.” This is because “FDA officials and six external stakeholder groups. .

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Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. The appropriations bills that expire March 1 include the Agriculture-FDA appropriations bill.

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FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. The evolving upswing in NDSRI regulation is due to their link to cancer. What is FDA doing about NDRSIs? By John W.M.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Dextrum Laboratories Inc.

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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. This is what OIRA is currently reviewing.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling.

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FDA Law Blog: Biosimilars

NOVEMBER 22, 2023

Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. §  180.30 , its interim authorization of the use of brominated vegetable oil (BVO) in in fruit-flavored beverages. BVO has been used as a flavoring oil stabilizer and emulsifier since the 1920s, and it was generally recognized as safe (GRAS) for this use by FDA.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market. By John W.M.

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FDA Law Blog: Biosimilars

JULY 24, 2023

After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA. Approximately six weeks after FDA approved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.

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FDA Law Blog: Biosimilars

AUGUST 27, 2024

This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. FDA Law Blog readers receive a 10% discount (use FDA Law Blog promo code: D10-999-FDA25).

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. FDA guidance has been clear that that point for rolling submissions is when the last component has been submitted.

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FDA Law Blog: Biosimilars

MARCH 15, 2023

s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. Hyman, Phelps & McNamara, P.C.’s

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. 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.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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