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With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms. The post Prescription Digital Therapeutics: When Software Is the Active Ingredient appeared first on Camargo. Blog Combination Products Device MORE
169 The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation. MORE
So you’ve determined that you need to perform juvenile animal toxicity studies as part of your nonclinical program. The next step is understanding why these studies are required and how they should be designed. Why Are Juvenile Nonclinical Studies Needed? MORE
Challenge. An international company developing an orphan drug product needed support navigating the US regulatory process from beginning formulation to NDA approval from a partner with experience in FDA interactions and a deep understanding of the Agency’s evolving thinking. Background. MORE
Whether you plan to out-license or commercialize your product, getting the label right matters. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo. Blog Commercialization MORE
Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct…. MORE
Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo. 505(b)(2) Development Blog DESI Drug Regulatory Strategy & Submissions MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection. MORE
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. MORE
Most are familiar with, know someone who uses, or take “pumps” themselves to prevent or relieve shortness of breath after an effort or during allergy season. MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication. MORE
On January 31, 2020, the Secretary of Health and Human Services (HHS) declared a national. The post Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify? appeared first on Camargo. Blog Regulatory Strategy & Submissions MORE
181 
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. MORE
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. MORE
Hydroxychloroquine. The world rallied around this old drug as a potential treatment of COVID-19 patients. The post Repurposing Drugs As an Answer to the COVID-19 Crisis appeared first on Camargo. 505(b)(2) Development Blog MORE
Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections has created a wealth of problems. MORE
This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. The post A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy appeared first on Camargo. 505(b)(2) Development Blog Clinical Studies, Phases I-IV MORE
As the COVID-19 national emergency stretches on in the United States, the eyes of the. The post What to Expect from the FDA During COVID-19 Product Development appeared first on Camargo. Blog Regulatory Strategy & Submissions MORE
Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations. MORE
Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. MORE
Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes. The post Patient-Centered Drug Development for Oncology Products appeared first on Camargo. MORE
Research into drugs and vaccines to combat the ongoing COVID-19 pandemic caused by the SARS-CoV-2. The post Choosing the Right Animal Model for COVID-19 Nonclinical Research appeared first on Camargo. Blog Nonclinical Testing MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Advice on Combination Products. MORE
In the first half of 2020 and as a direct consequence of the ongoing pandemic, China issued a ban on the export of non-human primates (NHPs) , including those used for pharmaceutical research. MORE
In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations. The post CARES Act Introduces OTC Administrative Order Process appeared first on Camargo. Blog Commercialization MORE
Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer. MORE
As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. MORE
In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year. MORE
Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility. MORE
Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo. Blog Clinical Studies, Phases I-IV MORE
Have you ever wondered about the difference between preclinical and nonclinical studies? While those in. The post Preclinical and Nonclinical Studies— What Is the Difference, and Where in Your Program Should They Fall? appeared first on Camargo. Blog Nonclinical Testing Services MORE
158 
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence. MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire. MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice. MORE
Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. MORE
Panel Summary from the World Orphan Drug Congress 2020. Last month, executives from leading international biopharma companies came together at the World Orphan Drug Congress 2020 to discuss how they are evaluating new opportunities in the rare disease space. MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues. MORE
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. MORE
When pitching to investors, a sponsor is not just selling them on the product; it is also selling them on its own ability to develop that product. Investors want to know the risks involved with the program, but they are also evaluating the sponsor as a risk factor of its own. MORE
Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages. MORE
Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species. MORE
Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. MORE
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. MORE
Camargo
JUNE 15, 2021
Challenge. An international company developing an orphan drug product needed support navigating the US regulatory process from beginning formulation to NDA approval from a partner with experience in FDA interactions and a deep understanding of the Agency’s evolving thinking. Background.
Camargo
JUNE 9, 2021
Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species.
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Camargo
JUNE 4, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod.
Camargo
MAY 19, 2021
The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation.
Camargo
MAY 10, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire.
Camargo
MAY 2, 2021
Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers.
Camargo
APRIL 20, 2021
Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer.
Camargo
APRIL 7, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues.
Camargo
MARCH 10, 2021
Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages.
Camargo
MARCH 9, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice.
Camargo
APRIL 28, 2021
Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility.
Camargo
MARCH 25, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.
Camargo
FEBRUARY 10, 2021
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high.
Camargo
FEBRUARY 24, 2021
Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success.
Camargo
JANUARY 19, 2021
Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date.
Camargo
JANUARY 14, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Advice on Combination Products.
Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.
Camargo
FEBRUARY 16, 2021
The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.
Camargo
SEPTEMBER 2, 2020
Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo. Blog Clinical Studies, Phases I-IV
Camargo
FEBRUARY 4, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication.
Camargo
MAY 19, 2020
As the COVID-19 national emergency stretches on in the United States, the eyes of the. The post What to Expect from the FDA During COVID-19 Product Development appeared first on Camargo. Blog Regulatory Strategy & Submissions
Camargo
MARCH 17, 2021
When pitching to investors, a sponsor is not just selling them on the product; it is also selling them on its own ability to develop that product. Investors want to know the risks involved with the program, but they are also evaluating the sponsor as a risk factor of its own.
Camargo
OCTOBER 15, 2020
As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider.
Camargo
JANUARY 27, 2021
Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations.
Camargo
SEPTEMBER 9, 2020
With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms. The post Prescription Digital Therapeutics: When Software Is the Active Ingredient appeared first on Camargo. Blog Combination Products Device
Camargo
DECEMBER 9, 2020
Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections has created a wealth of problems.
Camargo
OCTOBER 14, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence.
Camargo
JUNE 19, 2020
Hydroxychloroquine. The world rallied around this old drug as a potential treatment of COVID-19 patients. The post Repurposing Drugs As an Answer to the COVID-19 Crisis appeared first on Camargo. 505(b)(2) Development Blog
Camargo
DECEMBER 15, 2020
Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy.
Camargo
AUGUST 5, 2020
Whether you plan to out-license or commercialize your product, getting the label right matters. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo. Blog Commercialization
Camargo
MARCH 26, 2020
On January 31, 2020, the Secretary of Health and Human Services (HHS) declared a national. The post Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify? appeared first on Camargo. Blog Regulatory Strategy & Submissions
Camargo
NOVEMBER 24, 2020
Most are familiar with, know someone who uses, or take “pumps” themselves to prevent or relieve shortness of breath after an effort or during allergy season.
Camargo
AUGUST 13, 2020
Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo. 505(b)(2) Development Blog DESI Drug Regulatory Strategy & Submissions
Camargo
NOVEMBER 20, 2020
So you’ve determined that you need to perform juvenile animal toxicity studies as part of your nonclinical program. The next step is understanding why these studies are required and how they should be designed. Why Are Juvenile Nonclinical Studies Needed?
Camargo
JULY 1, 2020
This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. The post A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy appeared first on Camargo. 505(b)(2) Development Blog Clinical Studies, Phases I-IV
Camargo
SEPTEMBER 23, 2020
Panel Summary from the World Orphan Drug Congress 2020. Last month, executives from leading international biopharma companies came together at the World Orphan Drug Congress 2020 to discuss how they are evaluating new opportunities in the rare disease space.
Camargo
JANUARY 12, 2021
In the first half of 2020 and as a direct consequence of the ongoing pandemic, China issued a ban on the export of non-human primates (NHPs) , including those used for pharmaceutical research.
Camargo
JULY 29, 2020
Have you ever wondered about the difference between preclinical and nonclinical studies? While those in. The post Preclinical and Nonclinical Studies— What Is the Difference, and Where in Your Program Should They Fall? appeared first on Camargo. Blog Nonclinical Testing Services
Camargo
OCTOBER 8, 2020
Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct….
Camargo
SEPTEMBER 15, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection.
Camargo
JUNE 3, 2020
Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes. The post Patient-Centered Drug Development for Oncology Products appeared first on Camargo.
Camargo
MAY 8, 2020
In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations. The post CARES Act Introduces OTC Administrative Order Process appeared first on Camargo. Blog Commercialization
Camargo
MAY 6, 2020
Research into drugs and vaccines to combat the ongoing COVID-19 pandemic caused by the SARS-CoV-2. The post Choosing the Right Animal Model for COVID-19 Nonclinical Research appeared first on Camargo. Blog Nonclinical Testing
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