FDA Law Blog

DECEMBER 16, 2024

The final guidance appears not to make any meaningful changes that are actually likely to support or incentivize its increased utilization, which is disappointing, although not unsurprising. We noted in last years post that in Fiscal Years 2018 2022 , fewer than 100 510(k)s went through the Third Party Review Program annually.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

JULY 7, 2022

The first was to develop labeling beyond the DFL and the second was to propose “additional conditions that a consumer must fulfill” with the examples self-selection tests utilizing a mobile app or a requirement for the consumer to affirm they have watched a video or read text about use of the drug. This brings us back to the ANDAs.

Healthcare Professional 52

Healthcare Professional Utilities Provider IT 52

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

NOVEMBER 9, 2021

In September 2018, FDA took its first step towards electronic 510(k) submissions with its Quality in 510(k) Review Program Pilot, which we blogged about here. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021. Draft Guidance at 8.

Electronics 40

Electronics Physicals Provider Utilities 40

CDOCS

AUGUST 31, 2021

But, I still found myself utilizing the high strength glass ceramics because of their superior esthetics. CEREC SpeedFire Oven</span></em></p> <p style="margin-left:5pt;"><span style="font-size:14px;">The ability to now produce these restorations chairside was exciting for many of us.

Utilities 52

Utilities IT Clinic 52

FDA Law Blog

JUNE 16, 2023

Importantly, “price increase” is not defined in this statute. It appears not to mean a WAC increase, because the term WAC is specifically used in defining the price increase triggers, but not in reference to the manufacturer’s price increase. If a price increase is not an increase in WAC, its meaning is unclear. Is it an increase in AWP/SWP?

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. It’s not surprising that the number of repeat calls for falls is alarmingly high. Alex: I think this is a first.

Community 114

Community Transportation IT PCP 114

FDA Law Blog

JUNE 7, 2021

This sentence was included in the 2016 approval of Exondys 51 for Duchenne muscular dystrophy and the 2018 approval of Andexxa for reversal of anticoagulation therapy. This has been a decision we’ve been closely following. Key Takeaways from the Aduhelm Label: What’s in It and What Isn’t. What do we mean?

Clinic 98

Clinic IT Private Practice Utilities 98

FDA Law Blog

SEPTEMBER 5, 2023

FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy, FDA News Release (June 25, 2018). (DEA Schedule III placement would loosen registration requirements for researchers.

Medical 111

Medical IT Manufacturing Utilities 111

FDA Law Blog

JANUARY 4, 2023

Upon finalization of the guidance a year and a half later in June 2018 (which gave those who follow ad/promo guidance documents whiplash given the number of still-in-draft guidances) FDA expanded its enforcement discretion to include communications about unapproved uses of approved products. what is commercialization?

Patients 64

Patients Provider IT Utilities 64

The Clinical Problem Solvers

FEBRUARY 8, 2023

Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic. 2018 Jun;46(2):404-421. Jessica Isom and Dr. Helena Hansen] Dr. Jordan echoes these thoughts and posits that divergence from the “ideal” American identity (i.e., Mathis, M.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Is 4% meaningful? I think it’s you, Bob.

Patient-Centered 83

Patient-Centered IT Hospital Patients 83

GeriPal

FEBRUARY 24, 2022

Since then there has been a lot of back and forth, with even a couple of podcasts from us, several JAMA viewpoints, and most recently a series of published replies from leaders in the field on why ACP is still valuable (see below for references). . Despite all of these publications, I’m still left at a loss of what to think about it all.

Illness 98

Illness Patient-Centered IT Patients 98

PEMBlog

APRIL 4, 2024

But there are some challenges when it comes to the utilization of FOAM: – Decentralization of FOAM resources – Concerns about the quality of information being presented The Solution: The Systematic Online Academic Resource, or SOAR, review was created in an effort to address some of these limitations.

Education 59

Education Utilities Vaccination Provider 59

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Medicare negotiation authority; encourage biosimilars and generic drug utilization). Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98