Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only.

Routine Screenings 52

Routine Screenings Screening Complication Diagnose 52

PEMBlog

OCTOBER 31, 2024

Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. 2018 Nov 22;379(21):2002-2014. N Engl J Med 2018; 379:2015-2026. N Engl J Med.

Hospital 105

Hospital Illness Patients Provider 105

Medical Xpress

JANUARY 27, 2023

She researched rural states facing a shortage of behavioral health providers and accepted a job as a lead clinical primary therapist at Shodair Children's Hospital in Helena, Montana, in January 2018.

Hospital 72

Hospital Clinic Provider Medical 72

FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e.,

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

Medical 111

Medical Clinic Patients IT 111

The Medical Futurist

JUNE 21, 2025

Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018.

Diabetes 98

Diabetes Patient-Centered IT Patients 98

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

Diagnosis 59

Diagnosis Clinic Provider IT 59

FDA Law Blog

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

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Clinic Provider IT Patients 98

FDA Law Blog

JANUARY 15, 2024

If you made it through the first 2 pages of the opinion, this Court’s answer is clear: FDA flagrantly violated the APA in denying those flavored e-cigarette applications due to the Agency’s utter failure to provide comprehensible instructions and consistent policies. FDA also directed manufacturers to produce detailed marketing plans.

Manufacturing 115

Manufacturing IT Provider ER 115

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. The Journal of Clinical Psychiatry. 2018 May/Jun;79(3):17r11506. Pediatric Emergency Care. 2022;38(7):332-336.

Families 77

Families Family Patient-Centered Physicals 77

FDA Law Blog

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

Medical 98

Medical Manufacturing Healthcare Government 98

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 ).

Medical 64

Medical Electronics Manufacturing Utilities 64

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2018 Oct;142(Suppl 2):S72-S81. 2018-0333I.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

MAY 25, 2022

The safety communication acknowledges that the tests “may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality.” However, even with a low PPV, a test can provide clinically useful information to providers and patients.

Provider 40

Provider Screening Medical Patients 40

FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. 21 U.S.C. § 802(54)(D)(i).

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

APRIL 14, 2022

De Novo Requests: In the MDUFA IV commitment letter, FDA’s performance goal for review of de novo requests started with review of 50% of requests received in FY 2018 within 150 days of receipt, and increased 10% per fiscal year, ending with 70% within 150 days in FY 2022. We are, certainly, supportive of this effort.

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Provider Clinic Medical IT 40

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] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). As to the testing facility inspections, without more explanation than was provided in the preamble, it is not clear how section 513(a)(1)(C) provides authority. Part 860.

Manufacturing 52

Manufacturing Government Specialization IT 52

CDOCS

MARCH 31, 2021

& Below, a breakdown is provided for the number of appointments needed in the analog workflow (three appointments) compared to the digital CEREC Primescan iJIG workflow (one appointment).& Take clinical photos (7)<br /> 4. Send materials to the lab with clinical photos.</span></p>

Appointment 52

Appointment Family Families Patients 52

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

PEMBlog

MAY 11, 2023

Pediatr Emerg Care This randomized, double-blinded, placebo-controlled trial in infants 0-3 months old getting an LP, younger than 3 months, presenting to the ED meeting clinical criteria for LP. Neither HR nor NCFS differed, and perception of pain by provider, and need for additional lidocaine were similar. 2018 Mar;25(3):310-316.

Patient-Centered 52

Patient-Centered IT Provider Patients 52

FDA Law Blog

OCTOBER 5, 2022

eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps. eSTAR submissions are automated (e.g.,

Electronics 45

Electronics Medical Screening IT 45

FDA Law Blog

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. and more likely 15-20. A provision has already been included in H.R.

IT 40

IT Patients Provider Individual 40

GeriPal

JUNE 8, 2023

Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? Goldilocks zone). Eric: Let me ask you a question.

Diabetes 74

Diabetes Management Patient-Centered Family 74

Physician's Weekly

JUNE 19, 2025

The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. “We step into places where other providers may not, and geriatrics is a prime example of that.” ” In 27 states and Washington, D.C.,

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

Physician's Weekly

JUNE 19, 2025

Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018). Clinical Implications “Higher DII is independently associated with an increased risk of CHD, potentially through pathways involving metabolism, lipid levels, and kidney function.

Hypertension 52

Hypertension Individual Diabetes Diagnose 52