FDA Law Blog

DECEMBER 1, 2024

Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here ). Farquhar — A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection. 331(f)).

Management 113

Management IT Manufacturing Provider 113

FDA Law Blog

OCTOBER 3, 2022

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. This lawsuit was brought to the U.S. See United States ex rel. Bawduniak v. Biogen Idec, Inc. , 12-cv-10601-IT (D. Biogen first disclosed this tentative agreement in a quarterly earnings report in July of this year.

Consulting 105

Consulting Healthcare Professional Government Specialization 105

Physician's Weekly

JUNE 19, 2025

Gowin and his colleagues analyzed data from 1,003 adults between 22 and 36 years of age who had functional magnetic resonance imaging (fMRI), urine toxicology, and cannabis use results collected at one academic site between 2012 and 2015 as part of the Human Connectome Project. The cohort (mean age, 28.7

Community 52

Community Healthcare Diagnosis Medical 52

FDA Law Blog

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

Manufacturing 105

Manufacturing Management IT Medical 105

FDA Law Blog

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. What led to this conviction? It is a long story that started more than a decade ago. It involved Gree Electric Appliances Inc. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co.

Government 104

Government Insurance Manufacturing Individual 104

FDA Law Blog

MAY 13, 2024

Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. But by their very nature, RWD/RWE will have some gaps compared to randomized controlled trials.

Medical 111

Medical Clinic Patients IT 111

The Clinical Problem Solvers

MAY 9, 2021

The New Press: 2012. However it is important to remember that this political invention DOES affect biology because of the way that it creates social inequity. Historical Context: Historically, laws such as interracial marriage bans have protected established structures of white supremacy and reinforced the social construct of race.

Hypertension 52

Hypertension Clinic Patients IT 52

FDA Law Blog

DECEMBER 4, 2023

On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. Federal Court Orders San Antonio-Area Pharmacy and Pharmacist to Pay $275,000 Civil Penalty in Case Alleging Unlawful Opioid Distribution, Oct.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

PEMBlog

AUGUST 7, 2023

Pediatrics September 2012; 130 (3): 576–584. 2012-1671 Katz ES, Marcus CL. In children aged 2 to 5 years adenotonsillectomy has an 80% success rate if there is adenoid and tosillar hypertrophy. CPAP is an option for children older than 6 years (they can tolerate it better at that age). References Carole L. 10.1542/peds.2012-1671

Management 52

Management Diagnosis IT 52

Reflections of a Grady Doctor

JULY 30, 2019

Just like that ultra ordinary day in Jury Duty back in 2012. “And who knows but that you have come to your royal position for such a time as this?” - Esther 4:14 NIV A door had closed before her. It seemed like there was no way out. Some way, somehow our paths crossed. I went to Clark Atlanta,” she said over the email. It’s hard to explain.

Board-Certified 52

Board-Certified Medical Student Appointment IT 52

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

PEMBlog

MAY 1, 2025

Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. So as you can see, this virus does a lot of stuff. But what is it? Well, let’s get nerdy.

Complication 86

Complication Patient-Centered Patients Clinic 86

FDA Law Blog

MAY 19, 2025

By Larry K. Houck Last month the U.S. We have regularly posted on recognized prescribing red flags that pharmacists have ignored that resulted in administrative or civil actions by the Drug Enforcement Administration (DEA) including against Gulf Med and Coconut Grove pharmacies in Florida and Zarzamora Healthcare LLC in Texas.

Individual 64

Individual Patients Provider Medical 64

PEMBlog

OCTOBER 16, 2023

2012 Jan;5(1):67-70. The patient was diagnosed with OHVIRA syndrome: O bstructed H emi v agina with I psilateral R enal A nomaly (aka Heryln-Wener-Wunderlch syndrome). This syndrome can occur in the setting of uterine didelphys or a septate uterus with associated renal abnormality, most commonly associated with renal agenesis.

PCP 69

PCP PCP Diagnosis Diagnose 69

FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Prior to issuance of this Draft Guidance, information about this previously little-used process was included in a variety of sources we describe below.

IT 52

IT Clinic Provider Medical 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”. Among other things, the applicant would need to include a statement of the necessity of the ACNU.

Utilities 52

Utilities Healthcare Professional Provider IT 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. FDA-2022-E-3124 ).

Clinic 59

Clinic IT Provider Patient-Centered 59

FDA Law Blog

APRIL 16, 2024

It creates the prospect of larger inflation-based rebates, which make up an increasingly large portion of the total amount paid under the Medicaid Drug Rebate Program—more than half since 2012.”

Manufacturing 59

Manufacturing Provider IT 59

PEMBlog

JULY 17, 2023

8, 2012, pp. The original post was authored by Ashley Endres in 2018. this is an updated version for July 2023 Replace a G-tube Gastrostomy tube dislodgment and malfunction are top causes for G-tube related ED visits in pediatric patients so it is important to understand how to replace a G-tube. surgery or GI) before you mess with it.

IT 52

IT Families Family Complication 52

FDA Law Blog

APRIL 3, 2023

This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012. The amount of the additional rebate is the excess (if any) of a drug’s current Average Manufacturer Price (AMP) over the inflation-adjusted AMP for a statutorily specified baseline quarter. NDA or BLA) drugs.

Manufacturing 59

Manufacturing IT Clinic Provider 59

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. This is because, FDA explained, “ liberal does not mean unfettered.”

IT 52

IT Provider Medical 52

FDA Law Blog

MARCH 4, 2024

Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products. API and its source and any alternative sources; associated medical devices), and expected duration of the interruption.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

FDA Law Blog

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process. These legislative changes helped.

Specialization 69

Specialization Hospital Physicals Provider 69

FDA Law Blog

FEBRUARY 21, 2022

Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012. Unger joined CDER as the Deputy Director of the Division of Cardiovascular and Renal Products.

Patient-Centered 40

Patient-Centered Management Hospital Medical 40

FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinic 64

Clinic Relationship Provider IT 64

PEMBlog

MAY 11, 2023

2012 Jul;28(7):687-90. Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). PMID: 22743744.

Patient-Centered 52

Patient-Centered IT Provider Patients 52

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. By Holly N.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

APRIL 30, 2023

112-144 (2012). Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 110-85 (2007), as amended by Section 301 of Pub. Yeah, you read that correctly!

IT 59

IT Education Patients Provider 59

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. It harkens to the paternalism in medicine of the past.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

FEBRUARY 27, 2024

leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § Absent a convincing showing, the Office after considering all of Applicant’s argument plans to issue only one PTE directed to ZYDELIG® (idelalisib). l 56(c)(4) and 37 C.F.R.

Patients 59

Patients IT Provider Individual 59

Pamela Wible MD

JUNE 20, 2025

Since 2012, I’ve spoken to thousands of suicidal doctors—even published a book of physician suicide letters. It’s a growing crisis affecting over half of all doctors in the U.S., and it has been linked to rising rates of physician depression , doctor suicide , and medical errors. It is unclear to me who first applied the term to doctors.

Medical Student 246

Medical Student Diagnosis Physicals Medical 246

The Health Policy Exchange

MARCH 14, 2013

In July 2012, it was deja-vu all over again as AHRQ's budget was singled out for elimination by an appropriations subcommittee in the House of Representatives. The annual budget for the National Institutes of Health , for example, is typically around 100 times that of the Agency for Healthcare Research and Quality (AHRQ).

Family Medicine 130

Family Medicine DO Screening Medical 130

Common Sense Family Doctor

FEBRUARY 1, 2025

An analysis of Medicare data from 2012 to 2017 found that "using TCM codes was linked to a modest reduction in the number of patients readmitted to the hospital within 30 and 90 days after discharge, with the greatest improvements seen in 2017. More than a decade into the program, it remains uncertain whether TCM actually improves outcomes.

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. Objective: To measure and compare the proportion of primary care visits associated with mental health before and after the COVID-19 pandemic.

Primary Care 130

Primary Care Mental Health Illness Family Doctor 130

Common Sense Family Doctor

DECEMBER 4, 2024

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019.

Hospital 52

Hospital Management Patients Clinic 52

Common Sense Family Doctor

MAY 11, 2025

A less heralded ruling with health implications occurred in 2018, when the Roberts Court held that a prior federal law forbidding states to legalize sports betting was unconstitutional.

Management 52

Management Referral Mental Health Community 52

FDA Law Blog

JUNE 9, 2025

The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in 2012, directed FDA to investigate how well demographic subgroups (sex, age, race and ethnicity) were included in clinical trials to support approval of applications for medical products and whether subgroup-specific safety and effectiveness data were available.

Clinic 59

Clinic IT Healthcare Medical 59