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

AUGUST 27, 2024

The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials—critical competencies for legal and business professionals in the biopharmaceutical sector.

Small Molecule 59

Small Molecule FDA Regulations Production 59

FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

Regulations 64

Regulations FDA Laboratories Hospitals 64

Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

MARCH 19, 2024

Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. IVD Overview and Update,” will cover recent developments in IVDs, including the proposed LDT regulation. IVD Overview and Update,” will cover recent developments in IVDs, including the proposed LDT regulation.

Regulations 59

Regulations FDA Drugs 59

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

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 59

Compliance Regulations FDA Production 59

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. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.

Regulations 52

Regulations FDA Compliance International 52

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new 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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

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). The final rule will be effective on September 10, 2024.

Regulations 59

Regulations FDA Doctors Government 59

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.

Compliance 59

Compliance FDA Government International 59

FDA Law Blog: Biosimilars

JUNE 12, 2024

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids. The Agency “may issue technology specific regulations and guidance as new hearing technologies are approved and cleared by FDA.”

FDA 111

FDA Regulations Licensing Licensing 111

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. Comments may be submitted by September 30, 2024. By Adrienne R.

FDA 105

FDA Drugs Pharmacokinetics Production 105

FDA Law Blog: Biosimilars

JUNE 10, 2024

Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00-3:30 pm ET. Information and registration is available at the conference webpage here.

Regulations 59

Regulations Drugs Research 59

FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

Compliance 52

Compliance FDA FDA Approval Drugs 52

FDA Law Blog: Biosimilars

SEPTEMBER 3, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Not counting the two recent De Novo decisions that were not part of the original analysis, the total number of decision summaries posted for De Novos granted between CY 2022 and 2024 YTD is now 45/101 (43%). Gibbs — Thank you to readers of this blog.

Regulations 69

Regulations FDA 69

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Regulations 119

Regulations FDA Production Disease 119

FDA Law Blog: Biosimilars

AUGUST 14, 2024

On July 31, 2024, CMS published a proposed rule to codify its guidances, with some changes. We have drafted a memorandum that summarizes the main provisions of this proposed rule and notes where the regulation differs from the guidances.

Regulations 59

Regulations Pharmaceuticals Drugs 59

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. 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. By John W.M.

FDA 69

FDA Compliance Regulations Government 69

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 our co-chairs Kurt R. Karst (Director, Hyman, Phelps & McNamara, P.C.)

FDA 59

FDA Regulations Science Drugs 59

FDA Law Blog: Biosimilars

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

FDA 40

FDA Production Regulations Trials 40

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. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

Compliance 59

Compliance FDA Regulations Government 59

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). By now, more than a year ago, on October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims. By Riëtte van Laack — On Feb.

Regulations 52

Regulations Production Drugs 52

FDA Law Blog: Biosimilars

MARCH 24, 2024

On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. 22-3675, 2024 U.S. 2024) at 13 (“Decision”).

Pharmacy 59

Pharmacy Regulations Compliance Government 59

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. On August 8, 2024, the Court granted Nissan et al.’s FDA also consistently interpreted it that way between 1990 and 2007.

FDA 59

FDA Regulations FDA Approval Production 59

Agency IQ

SEPTEMBER 15, 2023

While fees payable for OTC Monograph Order Request (OMOR) submissions have previously been published in March, six months after the start of the fiscal year, the fees are now being published prior to the start of the 2024 fiscal year. This likely means that industry will have to wait until March 2024 for facility fee information.

FDA 40

FDA Government Drugs Production 40

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.” Comments on the draft guidance can be submitted to the docket by August 5, 2024. By Sarah Wicks & Anne K. Promote a culture of compliance and quality within the organization.

FDA 111

FDA Compliance Laboratories International 111

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

Laboratories 59

Laboratories FDA Regulations Compliance 59

FDA Law Blog: Biosimilars

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.

FDA 105

FDA Regulations Marketing Drugs 105

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

Biosimilars 40

Biosimilars Science FDA Licensing 40

FDA Law Blog: Biosimilars

DECEMBER 7, 2023

We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. On Day 2 of the conference, HPM’s Anne Walsh moderated a fascinating conversation about due diligence investigations relating to FDA-regulated industries.

Compliance 52

Compliance FDA Regulations Government 52

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. What is happening now? What does a shutdown mean for the FDA?

Government 40

Government FDA Biosimilars Regulations 40

FDA Law Blog: Biosimilars

AUGUST 7, 2024

While denying a Citizen Petition from Novartis asking FDA to refuse to approve any ANDA that omits the new dosing regimen or changes the indication, FDA approved MSN’s ANDA on July 24, 2024. Novartis further claims that the MSN labeling is unlawful because it violates the statutory requirement that the indications be “the same.”

FDA Approval 59

FDA Approval FDA Hospitals Regulations 59

FDA Law Blog: Biosimilars

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. When we reviewed the De Novos that were granted between CY 2022 and 2024, we saw that only 28% had decision summaries posted: Posted 2022 2023 2024 Total Yes 18 of 23 (78%) 9 of 48 (19%) 1 of 30 (3%) 28 of 101 (28%) Dishearteningly, the trend is in the wrong direction.

FDA 69

FDA Hospitals Production Regulations 69

FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. By Jeffrey N.

FDA 111

FDA Production Trials Pharmacy 111

Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

Science 40

Science FDA Biosimilars Production 40