FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state.

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FDA Law Blog: Biosimilars

MAY 3, 2023

the regulations formerly found in 21 C.F.R. As the first step in implementing this provision of the CARES Act, FDA issued a Federal Register notice on September 21, 2021, announcing the availability of the first group of deemed final administrative orders (see our blog post here ).

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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).

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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. She also hinted that such notices may become more common following the 2021 AMG v. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements.

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The Pharma Data

APRIL 8, 2021

The notes offering is expected to close on April 22, 2021, subject to customary closing conditions. persons outside the United States in reliance on Regulation S under the Securities Act. The notes have not been and will not be registered under the U.S.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. And in December 2021, we saw FDA apply those factors in responding to a citizen petition (Docket No.

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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. In 2022 and 2021, the Spring Unified Agenda was released in early/mid June.

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The Pharma Data

MARCH 5, 2021

Following final agreement, Novartis plans to start production in the second quarter of 2021. First deliveries of the bulk drug product to CureVac are expected in the summer 2021. Preparations for the start of production, technology transfer and test runs are already underway.

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The Pharma Data

MAY 18, 2021

Basel, May 18, 2021 — Sandoz, a Novartis division, today announces plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. About Sandoz.

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FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

In 2021, he was caught again, this time for selling a concoction of sugar and garlic that he claimed could prevent a whole slew of infections. Given the broad range of products regulated by FDA, the laundry list of activities prohibited under the FDC Act, and the scope of strict liability misdemeanor exposure, we respectfully disagree.

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FDA Law Blog: Biosimilars

AUGUST 8, 2023

The Guidance, which provides details about nitrosamines and FDA’s experience regulating them, explicitly applies to all finished drug products (including Rx, OTC, and unauthorized drugs), to “prescription and OTC drug products in clinical development,” and to both API and drug manufacturers. An earlier FDA guidance, revised in 2021.

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FDA Law Blog: Biosimilars

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.”

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Agency IQ

SEPTEMBER 15, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 11, 2023 6:44 PM CDT Regulatory background: User fees and over-the-counter (OTC) drug reform Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably. Read AgencyIQ analysis here.]

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The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. Rasi, who stepped down as executive director of EMA late last year, told the agency of his plans to take up two positions at the start of 2021.

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The Pharma Data

DECEMBER 3, 2021

The complete 12-month data from the zuranolone 30 mg cohort and original interim data from the zuranolone 50 mg cohort read out in early 2021. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. About Major Depressive Complaint (MDD).

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FDA Law Blog: Biosimilars

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA regulations also establish that “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec. 21 C.F.R. §§ 1306.04(a),

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The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. Remco Steenbergen, Chief Financial Officer of Deutsche Lufthansa AG since 2021, the largest airline group in Europe with approximately EUR 33 billion of sales in 2022.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. You see, Oncopeptides has has pending at the PTO since March 2021 a PTE application for U.S. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. 6,992,207 covering PEPAXTO (Docket No. FDA-2022-E-3124 ).

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FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

By Lisa M. (..)

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FDA Law Blog: Biosimilars

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Modifications that are not consistent with the authorized PCCP, however, must be evaluated in accordance with the traditional regulatory process described in applicable regulations and guidances referenced above. See 21 CFR 807.81(a)(3)

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

FDA also released, in December 2021, draft guidance for Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. By Adrienne R. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. In September 2021, FDA released a draft guidance on Electronic Submission Template for Medical Device 510(k) Submissions (see our blog ).

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan. The FTD is designed to make important new drugs accessible to patients faster.

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The Pharma Data

JANUARY 26, 2021

27, 2021 10:02 UTC. The full data analysis on 353 subjects would be available by the end of February 2021. HYDERABAD, India–( BUSINESS WIRE )– Dr. Reddy’s Laboratories Ltd. BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr.

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FDA Law Blog: Biosimilars

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. This approach to regulation of collection devices is overly burdensome and it discourages innovation. Cato & Jeffrey N. Gibbs & Allyson B.

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The Pharma Data

JULY 27, 2021

” In June 2021, AbbVie Inc. The acquisition is subject to customary closing conditions, including applicable regulatory approvals and is expected to close in the second half of 2021. exercised its right to acquire TeneoOne, Inc. (a anti-CD38 enzyme inhibitor) and TeneoTen, Inc. anti-HBV/CD3). Goldman Sachs & Co.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021. This extension does not include potential pediatric exclusivity. 2,3 In the U.S.,

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. In August 2021, FDA issued a press release announcing the denial of 55,000 flavored e-cigarette applications en masse. In Wages and White Lion Investments (DBA Triton Distribution) v. FDA failed on each count.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., of the total expenditures for all Part D drugs in 2021. had Part D expenditures on or before August 16, 2022).

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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.

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