FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

Regulations 44

Regulations FDA Production Government 44

The Premier Consulting Blog

MAY 11, 2023

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. Food and Drug Administration’s (FDA) released updated guidance following the landmark Genus Medical Technologies LLC v. injectables).

FDA 52

FDA Compliance Regulations Production 52

Pharmaceutical Development Group

JULY 7, 2021

Introduction FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products.

Production 52

Production FDA Packaging Vaccine 52

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. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. By Day 7 FDA sends Acknowledgment Letter.

FDA 75

FDA Packaging Laboratories Engineering 75

FDA Law Blog: Biosimilars

JULY 22, 2024

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.

Compliance 57

Compliance Production Packaging Government 57

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

Cytel

OCTOBER 23, 2023

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the two main divisions of the FDA responsible for regulating drugs and biological products, as well as combinations of drugs and biological products.

Packaging 69

Packaging Vaccine Regulations Production 69

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Recalls, Market Withdrawals & Safety Alerts Report a Problem to the FDA. ###.

Production 52

Production FDA Packaging Regulations 52

Agency IQ

FEBRUARY 12, 2024

FDA and EMA re-launch parallel advice pilot for complex generics The path to market for complex generics and hybrid products is complicated, and regulatory harmonization efforts in this space are lacking. FDA and EMA launched the Parallel Scientific Advice (PSA) Pilot Program for Complex Generic/Hybrid Products in September 2021.

FDA 40

FDA Packaging Production International 40

Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S.

FDA 40

FDA Disease Regulations Production 40

Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use.

FDA 40

FDA FDA Approval Production Regulations 40

FDA Law Blog: Biosimilars

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). not subject to premarket review).

FDA 98

FDA Regulations Production Packaging 98

FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

Production 62

Production Compliance Regulations FDA 62

Agency IQ

MARCH 7, 2024

FDA updates list of chemicals in the food supply under agency review The FDA has announced an update to its List of Select Chemicals in the Food Supply Under FDA Review, which details the agency’s ongoing post-market assessments for chemicals in human food.

FDA 40

FDA Regulations Packaging Marketing 40

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.

FDA 40

FDA Science Regulations Biosimilars 40

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.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

SEPTEMBER 6, 2023

But as a new guidance document clarifies, the FDA need to receive certain information from companies to make this meeting type work, and its not in a rush to receive requests, either. FDA Warning Letters are often sent to manufacturers of generic drugs.

FDA 40

FDA Packaging Drugs Production 40

Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics.

Production 40

Production FDA Compliance Packaging 40

FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

FDA 40

FDA Production FDA Approval Regulations 40

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

FDA 44

FDA Drugs FDA Approval Packaging 44

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ). patient and product characteristics).

FDA 40

FDA Production Regulations Vaccine 40

The Pharma Data

NOVEMBER 10, 2020

10, 2020 /PRNewswire/ — The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: “The FDA is investigating a third outbreak of Shiga toxin-producing E. brand packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. , coli O157:H7 (STEC).

FDA 52

FDA Packaging Production Vaccine 52

Agency IQ

JANUARY 26, 2024

FDA proposes first update to orthopedic device coating guidance since 1990s The FDA’s Center for Devices and Radiological Health (CDRH) has issued a new draft guidance specifically laying out the types of information it would want to see in pre-market submission for orthopedic devices with specific coating types.

FDA 40

FDA Animal Testing Packaging Regulations 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 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. FDA is also due to revise 24 other guidance documents at that time.

FDA 40

FDA Science Regulations Production 40

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.

Government 40

Government FDA Biosimilars Regulations 40

FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Devices can have both a UPC code and a UDI on their label and package. See 21 CFR 801.40(d).

Packaging 44

Packaging Compliance FDA Production 44

FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. b)(1)(iii).

Packaging 57

Packaging FDA Production Regulations 57

FDA Law Blog: Biosimilars

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984. And CVM certainly exercises that authority.

Drugs 57

Drugs FDA Licensing Licensing 57

The Premier Consulting Blog

NOVEMBER 16, 2022

Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

FDA 52

FDA Packaging Production Compliance 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. In 1997, FDA released regulations providing guidance on the use of electronic systems.

Compliance 52

Compliance Regulations Clinical Trials Packaging 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

Small Molecule 101

Small Molecule Government FDA Approval Regulations 101

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

FDA 40

FDA Science Drugs Regulations 40

Agency IQ

MAY 31, 2024

Shield is already available as a laboratory developed test (LDT), which allowed the sponsor to utilize a unique data set: Adherence The PMA for the Shield blood test was submitted to FDA in May 2023. The FDA raised the question of whether Shield should be considered a “first line” test or a “second line” test. Cologuard).

FDA 40

FDA Laboratories Compliance Packaging 40

The Pharma Data

FEBRUARY 13, 2022

One of the FDA’s signature efforts to improve our nation’s nutrition is focused on reducing the level of sodium in the food supply. The FDA took a critical step to help reduce sodium through a recently released guidance that establishes voluntary sodium reduction targets in processed, packaged and prepared foods.

FDA 40

FDA Government Packaging Disease 40

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Without sufficient resources, the FDA is unable to do so. modernization efforts.

FDA 40

FDA Drugs Production Licensing 40

The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., Also see the FDA’s FAQs on this topic.) The drug product is packaged and shipped as a solid powder.

Production 52

Production Efficacy & Potency Packaging FDA 52