The Clinical Problem Solvers

MARCH 14, 2025

There are a growing number of Child Psychiatric Access Programs, including one in Massachusetts, which provide quick access to psychiatric consultation and facilitates referrals for accessing ongoing behavioral health care. Diversifying your mental health outreach goes hand in hand with diversifying your providers. JAMA Netw Open.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. Providers should be aware of the other drugs prescribed to their patients. By Larry K. Holiday CVS, L.L.C.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

MAY 13, 2024

Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps. However, based on our experience reviewing device premarket submissions and engaging with FDA, we have found that reviewers have not embraced it in practice.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

DECEMBER 1, 2024

FDA has always claimed that this gives them the authority to take photographs while conducting an inspection, as reflected in its Investigations Operations Manual (at Section 5.3.4.1), provided that “photos are an integral part of an inspection.” 331(f)).

Management 113

Management IT Manufacturing Provider 113

The Clinical Problem Solvers

APRIL 24, 2025

The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. Suicide Trends Among Elementary School-Aged Children in the United States From 1993 to 2012. JAMA Netw Open. 2020;3(8):e2013100. doi:10.1001/jamanetworkopen.2020.13100 2020.13100 6.

Mental Health 52

Mental Health Community Hospital Appointment 52

FDA Law Blog

MAY 19, 2025

Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents (MMEs). 81, 89, 251.

Individual 64

Individual Patients Provider Medical 64

FDA Law Blog

AUGUST 10, 2023

Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Despite FDA having the authority to conduct paper inspections since the statutory provision was added to the FDCA by FDASIA in 2012, FDA did not issue a warning letter citing Section 704(a)(4) until January 2021.

Manufacturing 52

Manufacturing Electronics IT Physicals 52

FDA Law Blog

JULY 7, 2022

In March 2012 , FDA convened a public meeting to discuss a new paradigm under consideration, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Products Can Be Considered Nonprescription”. Drugs currently on the market OTC would not be approved with ACNU.

Utilities 52

Utilities Healthcare Professional Provider IT 52

FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Subsequently, CDER, in MAPP 6025.6 , and CBER, in SOPP 8212 , provided more granularity as to how this process would work with step-by-step instructions for FDA staff. Rescinded .

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

APRIL 16, 2024

In 2020, CMS issued a final rule providing a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” We wrote a memorandum summarizing CMS’ regulation here.

Manufacturing 59

Manufacturing Provider IT 59

FDA Law Blog

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

Specialization 69

Specialization Hospital Physicals Provider 69

FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

Clinic 59

Clinic IT Provider Patient-Centered 59

PEMBlog

MAY 11, 2023

Secondary outcomes included changes in heart rate (HR) and NFCS throughout the procedure, difficulty with LP, number of LP attempts, provider impression of pain control, additional use of lidocaine, skin changes at LP site, and LP success. 2012 Jul;28(7):687-90. 95% confidence interval = 1.01-3.93; 3.93; p = 0.04). Pediatr Emerg Care.

Patient-Centered 52

Patient-Centered IT Provider Patients 52

FDA Law Blog

APRIL 3, 2023

Over ten years after this statutory amendment, on December 31, 2020, CMS finalized a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.”

Manufacturing 59

Manufacturing IT Clinic Provider 59

PEMBlog

MAY 1, 2025

One review identified about 129 cases of parvovirus-related neurologic complications between 1970 and 2012, with encephalitis making up about two-thirds of those cases. These include encephalitis, Guillain-Barr syndrome, and brachial plexopathy. So how do we diagnose Parvovirus B19? Once the rash appears, the child is no longer infectious.

Complication 86

Complication Patient-Centered Patients Clinic 86

FDA Law Blog

JUNE 14, 2022

Though Esai’s Fycompa was initially approved in October 2012, it wasn’t scheduled until January 2014, meaning that Esai lost a little more than a year of patent life awaiting scheduling—in addition to the time spent in regulatory development and review.

IT 52

IT Provider Medical 52

FDA Law Blog

JUNE 23, 2021

In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm. 351, 355-56 (1985).

Patients 59

Patients IT Provider Individual 59

FDA Law Blog

APRIL 30, 2023

112-144 (2012). 1067 might allow these issues to be litigated months down the road therefore provides no solace: That’s far too late for patients, sponsors, and the broader public. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub.

IT 59

IT Education Patients Provider 59

Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

Hospital 52

Hospital Management Primary Care Primary Care Physician 52

Annals of Family Medicine

NOVEMBER 20, 2024

The time horizon was anchored in January 2012: pre-pandemic period was defined as January 2012 to March 2020, and the pandemic period as April 2020 to June 2022. Outcome Measures: The monthly prevalence was calculated as the percent of mental health visits (MHV) among all visits to a provider in that month.

Primary Care 130

Primary Care Mental Health Illness Family Doctor 130

Canadian Family Physician

FEBRUARY 18, 2025

Participants Older adults who are 65 years of age or older with advanced CKD and undergoing community-based nondialysis kidney care between April 1, 2012, and April 1, 2022, with at least 1 year of follow-up.

Primary Care 52

Primary Care Hospital Electronics Consulting 52

PEMBlog

JUNE 2, 2025

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. 2012 Sep 5;4:85-92. References: Bertazza Partigiani N, Spagnol R, Di Michele L, et al. Quick References 2024; 10.1542/aap.ppcqr.396258. Patel NH, Romero SK, Kaelber DC.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

FDA Law Blog

JUNE 7, 2021

It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. be “reasonably likely to predict” ultimate clinical benefit).

Clinic 98

Clinic IT Private Practice Utilities 98

FDA Law Blog

MARCH 13, 2023

The FDA took an early lead in the evolution of this movement when they launched the Patient Focused Drug Development (PFDD) initiative in 2012. Rather than speaking with one or two people with a condition of interest as had been previously done, they sought to find a more systematic way of getting broad patient and caregiver feedback.

Patients 98

Patients Patient-Centered Families Family 98

GeriPal

MARCH 7, 2024

We are delighted to welcome Jane Euler, who is lead doula and co-founder of Present for You, which is a benefit LLC company that provides doula support at the end-of-life. We are doulas for those with serious illness and those at end-of-life, just a longitudinal relationship, nonmedical support to provide presence. Jane: Right.

Provider 117

Provider Illness IT Healthcare 117

GeriPal

MARCH 2, 2023

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. And that’s because you’ve got other things that are absorbing simultaneously.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

PEMBlog

APRIL 26, 2023

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Healthcare providers need to be aware of and manage their biases concerning this topic, and that starts by ensuring that we ask all families about it.

Families 52

Families Family Mental Health Healthcare 52

FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. In the child with more severe symptoms or you’re worried about tracheomalacia, direct laryngoscopy including a diagnostic bronchoscopy in the OR under general anesthesia may provide a more comprehensive look at the Airway and the upper aerodigestive tract. Available from: [link] Hartl TT, Chadha NK.

Diagnosis 52

Diagnosis IT Diagnose Patients 52

FDA Law Blog

JANUARY 11, 2022

Amarin also sued Health Net, an insurer that provides coverage for both Vascepa and Hikma’s generic. Hikma countered that the notice of side effects for patients with CV disease is a warning, not an instruction to use the product in CV patients, and that Hikma has no duty to provide a statement discouraging an infringing use.

Insurance 52

Insurance Patients IT Manufacturing 52

FDA Law Blog

JANUARY 11, 2022

Amarin also sued Health Net, an insurer that provides coverage for both Vascepa and Hikma’s generic. Hikma countered that the notice of side effects for patients with CV disease is a warning, not an instruction to use the product in CV patients, and that Hikma has no duty to provide a statement discouraging an infringing use.

Insurance 52

Insurance Patients IT Manufacturing 52

PEMBlog

JUNE 5, 2024

2012 Jan 13;61(RR-1):1-20. I’ve provided a link in the show notes. Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. PMID: 22237112.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

FEBRUARY 2, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Eric: Yeah.

Consulting 121

Consulting Hospital Patient-Centered IT 121