FDA Law Blog

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Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

The Medical Futurist

JUNE 17, 2025

With AI tools having access to such information, they can instantly offer the best treatment options and probabilities of success. For instance, MouthWatch’s TeleDent service offers an all-in-one teledentistry platform allowing patients to capture images, send relevant information to a dentist remotely, and do a live consult.

Patients 126

Patients Treatment Plan Healthcare Medical Specialty 126

FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.”

Manufacturing 105

Manufacturing Provider Management IT 105

FDA Law Blog

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers.

Appointment 59

Appointment Manufacturing Medical Education 59

FDA Law Blog

MAY 6, 2024

For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions. Manufacturers are required to design, develop, and provide a “reasonable assurance” that both the cyber device and related systems (e.g., are cybersecure.

Medical 105

Medical Manufacturing Provider Management 105

FDA Law Blog

OCTOBER 4, 2022

By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. This acknowledgment will include an FDA-assigned identification number for the allegation report.

Manufacturing 52

Manufacturing Medical Provider IT 52

Physician's Weekly

JUNE 12, 2025

Food and Drug Administration (FDA) after the manufacturer, Church & Dwight Co., More information Read the full recall notice at the U.S. THURSDAY, June 12, 2025 (HealthDay News) — Some nasal and baby teething swabs from Zicam and Orajel are being recalled across the country because they may be contaminated with fungus, U.S.

Manufacturing 52

Manufacturing Illness Medical Family Practice 52

FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

Supply Chain 97

Supply Chain Manufacturing Provider IT 97

FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.

Manufacturing 52

Manufacturing Electronics IT Physicals 52

Medical Xpress

JANUARY 4, 2023

New research in the INFORMS journal Manufacturing & Service Operations Management finds that Medicare Advantage (MA), the largest healthcare capitation program in the U.S., unintentionally incentivizes health plans to cherry-pick profitable patients from traditional Medicare (TM).

Patients 92

Patients Manufacturing Healthcare Management 92

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This guidance document is still in effect today. use in education, construction, art, and jewelry).

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law Blog

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. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

Manufacturing 45

Manufacturing Provider IT Management 45

FDA Law Blog

MAY 29, 2025

Based on our experience with FDA review of 510(k) applications, a single document may be updated several times over the course of the review, and a document submitted in response to an FDA information request may completely replace a previously submitted document.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop.

Medical 23

Medical Manufacturing Electronics Provider 23

FDA Law Blog

JULY 23, 2024

A control strategy should be established to ensure that each lot of the final finished product is manufactured to conform to the design outputs. Information to include in IND, IDE, and marketing applications is also described within the draft guidance.

Manufacturing 105

Manufacturing Medical Clinic Provider 105

FDA Law Blog

JULY 29, 2024

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry is intended to be a roadmap that first describes the change notification process outlined in 21 C.F.R. Part 601 delineates those changes as being either major, moderate, or minor.

Manufacturing 64

Manufacturing Complication Government IT 64

FDA Law Blog

NOVEMBER 27, 2023

the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. 371), failure to immediately report required Information to the CPSC (15 U.S.C. §§ 2068(a)(4), 2070), and wire fraud (18 U.S.C. It involved Gree Electric Appliances Inc.

Government 104

Government Insurance Manufacturing Individual 104

FDA Law Blog

JUNE 15, 2022

Dara will be joining an expert panel as part of the Medical Affairs and Scientific Communications Track to discuss manufacturer communications related to Healthcare Economic Information (HCEI) and engaging with payers and formulary decisionmakers as part of Pre-Approval Information Exchange (PIE).

Healthcare 40

Healthcare Manufacturing Medical 40

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This guidance document is still in effect today. use in education, construction, art, and jewelry).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law Blog

FEBRUARY 7, 2023

For PMA devices, the marketing application contains quality system and manufacturing information, so getting started on the quality system in parallel to device development is important for a timely submission. There are many resources that provide information and guidance for each of these required elements.

Manufacturing 98

Manufacturing Medical Engineering IT 98

FDA Law Blog

JANUARY 18, 2023

They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. Approach for considering (1) the manufacturer-reported data elements and (2) evidence about alternative treatments. Process for the offer and counteroffer exchange between the Secretary and manufacturers.

Manufacturing 59

Manufacturing IT Provider Government 59

FDA Law Blog

MARCH 3, 2024

Biotechnology services include advising or consulting services related to the use of the above equipment, disease detection, or genealogical information, or any other service for the research, development production, analysis, detection, or provision of information including data storage and transmission related to biological materials.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law Blog

NOVEMBER 29, 2023

Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change. The evidence used to measure the device’s performance should be scientifically and clinically justified, consistent with the level of risk for the proposed change.

Management 115

Management Manufacturing Medical IT 115

CDOCS

AUGUST 11, 2021

I only had to adjust the mesial and distal contacts using the smooth tool and the restoration was ready to manufacture. The patient decided to inform me as we were placing the block in the milling machine that he also wants to whiten and wants to make sure his new crown will whiten along with his teeth!&

Manufacturing 52

Manufacturing IT Patients Relationship 52

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

Manufacturing 52

Manufacturing Asthma Diabetes Families 52

FDA Law Blog

NOVEMBER 1, 2022

USP aims to identify tools and solutions that may facilitate CART therapy development and mentioned potentially writing an information chapter on developing assays for CART therapies based on the workshop’s panel discussion. Agency often sees issues when the drug product is put on an expedited manufacturing or an expedited clinical program.

Manufacturing 59

Manufacturing Clinic Provider IT 59

FDA Law Blog

AUGUST 13, 2023

The information is presented in a Q&A format. Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In addition to the mandatory information to be submitted (i.e.,

Manufacturing 52

Manufacturing Electronics IT 52

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. See our previous coverage of such state laws here , here and here.) North Dakota.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

The Medical Futurist

JUNE 21, 2025

Compared to that, our hearing only processes 11 percent of information, while smell 3.5 Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device. percent, touch 1.5 percent and taste 1 percent. Don’t you think that’s possible?

Diabetes 105

Diabetes Patient-Centered IT Patients 105

FDA Law Blog

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

IT 104

IT Manufacturing Provider Medical 104

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

Manufacturing 72

Manufacturing Government Healthcare Management 72

FDA Law Blog

APRIL 2, 2025

FDA and the court agreed that the law does not require manufacturers to get preapproval before using a substance the manufacturer believes to be GRAS. The Government argues that the FDCA is silent on whether the manufacturer must notify FDA of GRAS conclusions. [A]s

Manufacturing 59

Manufacturing Government IT 59

FDA Law Blog

OCTOBER 3, 2022

For example, the government closely scrutinizes speaker programs or trainings that involve lavish venues or meals and free alcohol, invite attendees with no legitimate business reason to attend, and present little substantive information to them. Today, these two documents are key in navigating speaker programs in the industry.

Consulting 105

Consulting Healthcare Professional Government Specialization 105