scholarly journals The US Food and Drug Administration's tentative approval process and the global fight against HIV

2017 ◽  
Vol 20 (4) ◽  
pp. e25019 ◽  
Author(s):  
Harinder Singh Chahal ◽  
Jeffrey S Murray ◽  
Martin Shimer ◽  
Peter Capella ◽  
Ryan Presto ◽  
...  
Keyword(s):  
Approval Process ◽  
The Us ◽  
Tentative Approval

scholarly journals Current State of Regulatory Oversight of Biosimilars in India and Its Implications on the Quality of Drugs: A Comparative Assessment with EU and FDA Regulations

2021 ◽  
pp. 1-7
Author(s):  
Vikram Gota ◽  
◽  
Diana Varghese ◽  
Shayma Karbelkar ◽  
◽  
...  
Keyword(s):  
Quality Characteristics ◽  
Patient Access ◽  
Approval Process ◽  
Regulatory Oversight ◽  
Medical Needs ◽  
Current State ◽  
The Us ◽  
Improve Patient ◽  
Unmet Medical Needs

Biosimilars are biologic products that are highly similar to a licensed reference biologic, with no clinically meaningful differences in quality characteristics, biological activity, safety, or efficacy. Biosimilars can help to fulfill unmet medical needs due to their cost effectiveness while at the same time being as efficacious as the innovator drug. They can also improve patient access to otherwise costly innovator biologics. India has the largest number of approved biosimilars as compared to the US and Europe. However, the numbers of clinical studies that are conducted to prove the biosimilarity are lesser than the number of biosimilars approved, which is evident by the number of CTRI registrations done. Some studies have shown the quality of biosimilars approved and marketed in India to be inferior to the innovator drug. This raises concerns regarding the quality of the biosimilars. In this review, the similarities and differences in the guidelines, the approval process, and quality enforcement measures prevailing in the three regulatory regions of USA, Europe and India are discussed. Changes in the approval process and post approval monitoring of drugs and manufacturing facilities are recommended in order to ensure sustained quality standards of drugs entering the market.

scholarly journals Communicating Effectively About Emergency Use Authorization and Vaccines in the COVID-19 Pandemic

2020 ◽  
pp. e1-e4
Author(s):  
Sandra Crouse Quinn ◽  
Amelia M. Jamison ◽  
Vicki Freimuth
Keyword(s):  
Diagnostic Procedure ◽  
Approval Process ◽  
Off Label Use ◽  
Off Label ◽  
Risks And Benefits ◽  
The Us ◽  
Life Threatening ◽  
Potential Benefits ◽  
Accelerated Approval ◽  
Potential Risks

The Emergency Use Authorization (EUA) mechanism is central to the US response to coronavirus disease 2019 (COVID-19). It allows the US Food and Drug Administration (FDA) to respond quickly to novel threats by approving a new drug, device, or diagnostic procedure or expanding off-label use of an existing drug through an accelerated approval process.1 To obtain authorization, evidence must support that a drug or product “‘may be effective’ to prevent, diagnose, or treat serious or life-threatening diseases or conditions,” and the known or potential benefits of the product must outweigh known or potential risks.2(p7) The authorization also stipulates that when feasible, a fact sheet is provided to address risks and benefits and make clear that acceptance is voluntary.2 (Am J Public Health. Published online ahead of print November 25, 2020: e1–e4. https://doi.org/10.2105/AJPH.2020.306036 )

Investigational Therapy and Drug Approval Process within the US and Cannabidiol

Epilepsy ◽  
2021 ◽  
pp. 287-300
Author(s):  
Gregory Sprout ◽  
Joseph I. Sirven ◽  
Gregory D. Cascino
Keyword(s):  
Drug Approval ◽  
Approval Process ◽  
The Us ◽  
Drug Approval Process

The US FDA in the Drug Development, Evaluation and Approval Process

2013 ◽  
pp. 501-517
Author(s):  
Richard N. Spivey ◽  
Judith K. Jones ◽  
William Wardell ◽  
William W. Vodra
Keyword(s):  
Drug Development ◽  
Approval Process ◽  
The Us ◽  
Development Evaluation ◽  
Us Fda

scholarly journals Public opinion on coronavirus vaccination 1: A majority of Americans would take the existing Russian vaccine and believe that they ought to be allowed to buy it

2020 ◽  
Author(s):  
Jonathan Kelley ◽  
MDR Evans ◽  
Charlotte Corday
Keyword(s):  
Public Opinion ◽  
Government Policy ◽  
Approval Process ◽  
National Surveys ◽  
The Us ◽  
Us Government ◽  
Republican Government ◽  
Considerable Period ◽  
New Vaccines ◽  
Do So

In the US new vaccines are banned until shown to be safe and effective. But the approval process is slow and cautious and no vaccine has yet been approved. The faster but perhaps riskier Russian system produced an approved coronavirus vaccine months more quickly, leaving Americans at risk of dying for months longer than Russians. Our data from two national surveys in September show that a majority of Americans would willingly take the existing Russian vaccine and that a two-to-one majority – rich and poor, young and old, Democrat and Republican alike – believe that they ought to be allowed to do so. We estimate that making the Russian vaccine immediately available would save approximately 40 to 100 American lives each day after the first month and many more subsequently, To put the matter bluntly, current US government policy will kill some 40 to 100 people each day for a considerable period later this year and early next. To put those deaths in context, all American murderers combined kill only 45 people each day – not a record the US government should wish to emulate. There are also implications for the 2020 election; Since feelings about the Russian coronavirus vaccine are strongly favorable, and the benefits of allowing it in the US are large, making it available should be attractive politically. The Republican government has the power to adopt that policy and gain the credit. Alternatively, the Democratic opposition has the opportunity to advocate that policy, and claim the credit.

The US FDA in the Drug Development, Evaluation and Approval Process

2007 ◽  
pp. 602-613
Author(s):  
Richard N Spivey ◽  
Judith K Jones ◽  
William Wardell ◽  
William Vodra
Keyword(s):  
Drug Development ◽  
Approval Process ◽  
The Us ◽  
Development Evaluation ◽  
Us Fda

Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids

2017 ◽  
Vol 13 (6) ◽  
pp. 379 ◽  
Author(s):  
Christopher J. Miller, MS ◽  
Richard C. Dart, MD ◽  
Nathaniel P. Katz, MD, MS ◽  
Lynn R. Webster, MD, FACPM, FASAM
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Clinical Data ◽  
Marketing Approval ◽  
Current Policy ◽  
Approval Process ◽  
Advisory Committees ◽  
Expert Advisory ◽  
The Us ◽  
Regulatory Decisions

It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data submitted by the sponsor are sufficient to support marketing approval and labeling of the product with properties expected to deter abuse by specific routes of abuse (ie, oral, intranasal, intravenous). The FDA has typically followed the approval and labeling recommendations for ADFs reviewed by its Advisory Committees, highlighting the importance of these meetings in the regulatory approval process. This review describes common issues considered by Advisory Committees for ADF opioids as well as insights on how to prepare for these meetings based on recent relevant experience and regulatory decisions.

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