FDA Law Blog

JUNE 2, 2025

The letter, which FDA issued on March 31, 2025 (but only posted on its website last week), was only one of two that FDA has sent in the last five years and only one of five that FDA has issued since finalizing its RUO Guidance in November 2013 (see guidance here ).

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IT Manufacturing Government Clinic 64

Physician's Weekly

JUNE 24, 2025

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. So, in 2016, she celebrated her 60th birthday at her local CVS.

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Sound Physicians

OCTOBER 30, 2024

I went to the University of Toronto and finished my Bachelor of Science there in 2013. I wanted to get back to where we were, to give back to the program that gave my career a place to start, and to provide stability to my fellow providers. When prospective providers visit Mercy Hospital of Buffalo team.

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Hospital Telemedicine Healthcare Provider 52

Medical Xpress

JANUARY 17, 2023

The My Life, My Story (MLMS) project was established through the Veterans Health Administration in 2013 with the goal of bringing the patient's voice into their medical record.

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Medical Provider Patients IT 75

FDA Law Blog

AUGUST 2, 2022

Cole providing guidance to U.S. Attorneys in August 2013 advising that DOJ would not take enforcement action against marijuana-related businesses operating in compliance with state law unless the businesses implicated one of eight specified enforcement priorities. 21 U.S.C. § 812(b)(1). 3 (July 5, 2022) [hereinafter CRCC Letter].

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Medical Individual Provider Community 96

Aspiring Minority Doctor

OCTOBER 23, 2021

If you've been following my blog since it's inception in 2013, then you already know how much of an inspiration Dr. Barbara Ross-Lee is to me. Hopefully one day I can give back and serve as an inspiration to someone just like many individuals such as Dr. Barbara Ross-Lee who provided inspiration and encouragement for me :)

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Medical Student Doctor of Osteopathic Medicine Medical Education 52

FDA Law Blog

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers. 6,708 (Feb.

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Supply Chain Provider Government Complication 52

FDA Law Blog

DECEMBER 1, 2024

To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken. . Farquhar — A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection.

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Management IT Manufacturing Provider 113

FDA Law Blog

MAY 2, 2022

In response to states authorizing and legalizing marijuana while it remained a schedule I substance federally, Deputy Attorney General James Cole provided guidance in a memorandum to U.S. 29, 2013 , 3. Cole, Memorandum for All United States Attorneys, 2013 , at 1-2. 26, 2022, (01:06:35). Hearing 116-65 , at 70 (Jan.

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Manufacturing Medical IT Community 52

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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GeriPal

APRIL 27, 2023

The company has expanded its palliative care services through partnerships with hospitals and other managed care providers, according to AccentCare CEO Stephan Rodgers. Palliative Care the Next Generation: How the Service May Grow and Evolve AccentCare , a portfolio company of private equity firm Advent International, is another example.

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Specialization Illness Healthcare Patient-Centered 93

FDA Law Blog

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The comment period for the Proposed Rule will remain open until June 4, 2022 (120 days after publication). See 21 U.S.C. 360eee-4(b)(2).

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CDOCS

JUNE 3, 2021

</span></p> <p><span style="font-size:14px;">Greg came to my practice initially in 2013 as a new patient. Ultimately, we can still provide an esthetic, biological and functional improvement while knowing the compromises in advance.& I present to you Greg.</span></p>

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Patients Treatment Plan IT Diagnose 52

FDA Law Blog

AUGUST 8, 2024

Will DOJ and DEA continue to exercise the enforcement discretion generally shown since the Cole Memo was issued in August 2013? Merrick Garland may not be Attorney General if DEA takes scheduling action on marijuana, but if he is, he may have provided a clue during his confirmation. 21 U.S.C. §

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Government Medical IT Manufacturing 59

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? But before we do, do you have a song request? I think Kellie, do you have it? Alex: Yeah.

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Hospital Patient-Centered IT Nurse Practitioner 101

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.

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IT Clinic Provider Medical 52

FDA Law Blog

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.

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Supply Chain Electronics Manufacturing Provider 52

FDA Law Blog

DECEMBER 13, 2023

However, our research reflects that of the orphan-designated novel drugs approved since 2013 by DRDMG or its predecessor, the Division of Gastroenterology and Inborn Errors Products (DGIEP), only 1 out of 18 went to an advisory committee meeting. Note that FDA is currently soliciting applications to staff this committee.

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FDA Law Blog

APRIL 26, 2021

Koblitz — So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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FDA Law Blog

APRIL 26, 2021

So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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ER IT Utilities Provider 40

FDA Law Blog

MARCH 6, 2022

Through MDSAP, FDA determined that ISO 13485 “provides a comprehensive and effective approach to establish a QMS for devices.” And FDA has issued Form 483s and Warning Letters to companies for failing to have adequate procedures in compliance with the QSR, despite those companies’ arguments that ISO compliance ensures safety and effectiveness.

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Manufacturing Management Medical Provider 52

FDA Law Blog

JUNE 17, 2024

Instead, the State of Pharmaceutical Quality Report provides more detailed statistics and data from FY2023 (October 1, 2022—September 30, 2023), and a clearer window into enforcement priorities. While no office at FDA truly works in a vacuum, we can safely call OPQ the tip of FDA’s quality spear. Every American consumer expects the U.S.

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Manufacturing IT Provider Medical 59

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. The ability to track changes and provide and respond to comments is an important part of this process.

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Electronics Physicals Provider Utilities 40

FDA Law Blog

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. the wholesale distributor, repackager, relabeler). Draft Guidance III.B.2(d)

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Supply Chain Manufacturing Physicals Healthcare 52

FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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PEMBlog

OCTOBER 2, 2024

Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting. 2013-0421 Tighe M, Afzal NA, Bevan A, et al. I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. doi: 10.1097/MPG.0000000000001889

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Diagnosis Management IT Patient-Centered 52

FDA Law Blog

APRIL 30, 2021

Despite FDA’s historical policy of not ruling on ANDA suitability petitions within the statutory deadline, leading to a loss of faith in the process itself, FDA, in August 2013, published a Manual of Policies and Procedures (“MaPP”) – FDA, Manual of Policies and Procedures, Office of Generic Drugs: ANDA Suitability Petitions, MaPP 5240.5 (Aug.

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IT Clinic Government Provider 40

FDA Law Blog

APRIL 30, 2021

Despite FDA’s historical policy of not ruling on ANDA suitability petitions within the statutory deadline, leading to a loss of faith in the process itself, FDA, in August 2013, published a Manual of Policies and Procedures (“MaPP”) – FDA, Manual of Policies and Procedures, Office of Generic Drugs: ANDA Suitability Petitions, MaPP 5240.5 (Aug.

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IT Clinic Government Provider 40

The Health Policy Exchange

SEPTEMBER 16, 2013

Supporters of evidence-based preventive medicine cheered when the Affordable Care Act required Medicare and private health insurers to provide first-dollar coverage for all preventive services assigned an "A" or "B" recommendation grade by the U.S. Preventive Services Task Force.

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Screening Family Medicine DO Insurance 130

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.

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Hospital Management Primary Care Primary Care Physician 52

GeriPal

JUNE 19, 2025

This is like, back in 2013, and I joined the faculty at the Icahn School of Medicine at Mount Sinai. So when I joined Sinai In 2013, I was in a different form at that time. Jace, welcome to the GeriPal Podcast. Jace 00:37 Thank you so much, Alex and Eric, it’s nice to be here with you. Eric 01:21 Why’d you choose this song?

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Individual Community IT Chronic Condition 82

GeriPal

SEPTEMBER 1, 2022

In day-to-day practice, It’s hard to imagine providing excellent hospice or palliative care services without access to a team social worker. Barbara: Oh, I think it was 2013. Now, my SWHPN friends will get mad at me if I got that wrong, but I think it was 2013. Summary Transcript Summary. by: Anne Kelly, LCSW, APHSW-C.

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IT Families Family Clinic 102

The Clinical Problem Solvers

MARCH 4, 2024

It also helps illustrate the power of witnessing and mutual recognition, where there is a narrative exchange between patient and provider, with a validation of patients’ suffering. Sayantani became a physician since she thought it was a concrete tool for social justice. Stories are not inherently just.

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Community Education Patient-Centered Relationship 52

ABIM

JUNE 4, 2025

Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.”

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Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 24, 2025

Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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ABIM

JUNE 11, 2025

Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.” The group discussed some of Dr. McDonald’s updates in greater detail.

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ABIM

MAY 30, 2025

Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.” Rodriguez, MD , Chair of the Nephrology Board, and John C.

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