FDA Law Blog

JUNE 2, 2022

Until August 2021, the pre- and post-1984 ANDA was a distinction without a difference: FDA treated the pre-1984 follow-on applications as ANDAs and listed them in the Orange Book as ANDAs even though they technically are NDAs. Nor has FDA initiated a rulemaking to implement its changes to the regulatory scheme governing PANDAs.

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Tiny Physician

FEBRUARY 15, 2022

Incompetent government The doctor-patient ratio of India is one of the worst in the world; we have 1 doctor for 1456 people against the WHO recommendation of 1:1000 [5]. There is only 1 government doctor for a population of 11,000 people and there is only 1 dental surgeon per 175,000 people [6].

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FDA Law Blog

JANUARY 31, 2023

I read the provisions of the new law and saw two provisions that seemed to be possible stumbling blocks that could be frustrating uptake of the new law: (1) a provision required that to be designated an orphan drug, a sponsor had to prove that it could not recoup its research & development costs during the 7 years of market exclusivity— essentially (..)

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FDA Law Blog

MAY 26, 2022

This proposal would substantially increase the likelihood that generic versions of patent-protected drugs will come into the market in a timely fashion, and that multiple versions of generic products will be approved quickly (leading to significant cost savings).

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FDA Law Blog

MARCH 30, 2022

This proposal would substantially increase the likelihood that generic versions of patent-protected drugs will come into the market in a timely fashion, and that multiple versions of generic products will be approved quickly (leading to significant cost savings).

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FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly. Modernizing Therapeutic Equivalence Rating Determination Act (S.

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FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly. Modernizing Therapeutic Equivalence Rating Determination Act (S.

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The Clinical Problem Solvers

OCTOBER 11, 2021

In contrast, de jure segregation refers to the involvement of federal, state, and local governments in creating, structuring, designing, reinforcing, and perpetuating segregation. The Color of Law: A Forgotten History of How Our Government Segregated America. Rothstein shares two examples of potential remedies to segregation.

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FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

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Tiny Physician

MAY 25, 2022

Governments declare war, but it is the civilians who suffer. Malavika completed her higher secondary education in the year 2017, and then she dropped one year for entrance exam preparation; however, her rank was not good enough to secure a government seat in Kerala. Hence, we got tickets for flights in the second week of March.

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GeriPal

MAY 12, 2022

He is also author of the book, “ Walk with the Weary: Lessons in Humanity in Health Care ,” and was featured in this Atlantic article. I have written about it in the book. So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college.

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GeriPal

SEPTEMBER 29, 2022

Janet is the author of the 4th edition of the book Comprehensive Guide to Supportive and Palliative Care for Patients with Cancer, along with co-authors Molly Collins and BR Daubman. This book is terrific, truly comprehensive, and is a go to resource for when I’m “stuck” taking care of patients with cancer. . Janet: Beautiful.

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Tiny Physician

MARCH 30, 2022

During the second wave of COVID, a government doctor in Madhya Pradesh resigned after a few Congress leaders verbally abused him following the death of a COVID patient. All the brutal acts are happening despite the central government issuing an ordinance making acts of violence against healthcare professionals a non-bailable offense.

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GeriPal

NOVEMBER 17, 2022

Sheryl: Largely the people who live there as opposed to government funds. And it’s interesting there because long-term care is covered by the government, but still assisted living has emerged as a private market to try and accommodate some of this demand for supportive services. Eric: And who pays for assisted living communities?

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GeriPal

MARCH 16, 2023

Summary Transcript Summary So you want to write a book. So you want to write a book! So…you want to write a book?!? You can hear our prior podcast on Louise’s book here ). We talk with them about writing for the lay public, including: Why write a book for the lay public? How did they start writing a book?

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GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding.

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Doctor Rachel

FEBRUARY 17, 2019

I also mention a number of books throughout, which give more detailed accounts of the points discussed.) book, Eight Dates: Essential Conversations for a Lifetime of Love , with John and Julie Gottman, is an attempt to share this life-changing practice of “dating” for a lifetime with others. Our recently released (and now bestselling!)

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GeriPal

APRIL 13, 2023

Because our division of geriatrics has such expertise in secondary data analysis and how their retirement studies, can set me off on this task to go read the code books in HRS. You can use it on one thing to either have government, individual providers, healthcare systems do one thing differently. Lightning round: magic wand.

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GeriPal

MARCH 24, 2023

And welcome back to the GeriPal podcast, Ira Byock, who is a author and well-known, has written several books about hospice, inspired many to go into the field, and is the founder of- Ira: The Institute for Human- Alex: The Institute for Human Caring. Joseph: Yes, This is the first time. I’m excited. Alex: Welcome.

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GeriPal

MARCH 6, 2025

But for me to really get comfortable in palliative practice, I had to go book like other rotations and spend some, some extra time with people who do addiction health, people who, you know, I spent time with the outreach nurses who are doing, you know, street outreach visits. Government is not the 51st state.

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GeriPal

APRIL 18, 2024

So in truth, I called it a b r because the Book On B t, you ever read that, Bob? Eric: Yeah, great book. And I remember interviewing Captain Sullenberger for my book, and as he was describing accidents like this, he said, “They were flying a plane they were not familiar with, which is a plane without their digital wingman.”

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GeriPal

SEPTEMBER 5, 2024

Her most recent book is Elderhood. He made it very clear that he called me by looking my number up in the phone book. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. Eric 00:13 And, Alex, who do we have with us today? Louise, welcome back to GeriPal. Bill 42:22 I did not.

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Common Sense Family Doctor

FEBRUARY 21, 2025

(Oh, and the CDC's National Immunization Survey has been canceled by the so-called Department of Government Efficiency, even if the Epidemic Intelligence Service seems to have received a temporary reprieve.) This real-life scenario is probably Dr. Adam Ratner's worst nightmare, but it couldn't have come at a better time for his book.

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Physician's Weekly

JUNE 27, 2025

” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition. The federal government could do more to encourage medical professionals to go into primary care and rural health care.

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GeriPal

DECEMBER 21, 2023

There’s a book called The 36-hour day for dementia caregivers. Just to let you know, Eric, we have to give the credit to our federal government. Our alliance is governed by a steering committee and we go to them and say what are the areas? There’s a reason that’s in… How many prints? Diane: Yeah.

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Physician's Weekly

JUNE 13, 2025

” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?”

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Physician's Weekly

JUNE 25, 2025

In the 1980s, the government refused to acknowledge HIV as gay men died young. He saw how care bolstered lives, but the federal government needed data to drive its approach to HIV. Not Bowing to Barriers Researchers and HIV advocates are hashing out strategies to fill in the vacuum in HIV care that the government is poised to leave.

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FDA Law Blog

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. The government would require at least another 30 days to examine the shipment at the U.S. Information related to the importation (e.g.,

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GeriPal

APRIL 17, 2025

I had the pleasure of listening to this book with Farah reading it. It is a terrific book. If you read Edwin Baptiste’s book about cotton and slavery, you see that from over a 40 year period, slaves were tortured to produce four times as much cotton as they had to produce just 40 years earlier. Well played.

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IT Community Government Management 70

Physician's Weekly

JUNE 27, 2025

Some of the nation’s most popular beaches are managed by the National Park Service, which saw about 1,000 employees laid off in February by the Department of Government Efficiency, or DOGE, which was created by executive order and overseen by billionaire Elon Musk through May.

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