Search Results for FDASIA

Showing 1 – 25  of 92

FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement By Zachary Brennan - Published 18 August 2017

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

Categories: News, US, FDA, Biologics and biotechnology, Clinical

Tags: PREA, FDASIA, non-compliance letters FDA

FDA Updates Guidance on Collecting Race, Ethnicity Data in Clinical Trials By Michael Mezher - Published 01 November 2016

The US Food and Drug Administration (FDA) recently updated its 2005 guidance detailing its expectations sponsors for collecting race and ethnicity data in clinical trials for drugs, biologics and medical devices.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: Race, Ethnicity, Clinical Trial Participation, FDASIA

Pediatric Study Plans: FDA Unveils Revised Draft Guidance By Zachary Brennan - Published 08 March 2016

The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Drugs

Tags: pediatric study plans, iPSP, PREA, FDASIA

Custom Devices: Improving Patient Quality of Life and Clinician Capabilities By Carol Vierling - Published 19 November 2015

This article discusses the definition of a custom device, how a custom device is developed and regulations to be followed to place a custom device on the market. The article also discusses when a compassionate use request may be appropriate.

Categories: Features, US, CDRH, Compliance, Medical Devices

Tags: Custom Medical Devices, Custom Device Exemption, FDASIA, Patient-Specific Devices, Compassionate Use

FDA Finalizes Six-Month Drug Shortage Notice Regulation By Michael Mezher - Published 08 July 2015

A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages.

Categories: Biologics and biotechnology, Communication, Crisis management, Drugs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: Drug shortages, FDASIA

Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers By Alexander Gaffney, RAC, Michael Mezher, Zachary Brennan - Published 02 October 2017

Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Research and development, Submission and registration

Tags: Priority Review Voucher, PRV, Neglected Tropical Disease, Neglected Tropical Disease Priority Review Voucher, Rare Pediatric Disease Voucher, Rare Pediatric Disease, FDASIA, FDAAA, Voucher, FDA Voucher, Guidance, AbbVie, United Therapeutics, Praluent

Patient-Focused Drug Development Tracker By Alexander Gaffney, RAC - Published 01 July 2015

The US Food and Drug Administration's patient-focused drug development program is poised to overhaul how drugs are approved for rare and inadequately served diseases and conditions. This tracker provides an in-depth look at what questions FDA is asking of patients and their representatives.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs, Orphan products

Tags: Patients, Patient-Focused Drug Development, FDASIA, View of Patients, PFDD

FDA Kicks off Reauthorization Process for PDUFA By Alexander Gaffney, RAC - Published 12 May 2015

The US Food and Drug Administration (FDA) has announced the start of the next reauthorization process for the Prescription Drug User Fee Act (PDUFA), a major framework under which most new drug products in the US are reviewed.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: PDUFA, FDASIA, PDUFA Reauthorization, PDUFA VI

FDA Substantially Increasing its Inspections of Foreign Generic Drug Companies By Alexander Gaffney, RAC - Published 06 May 2015

The US Food and Drug Administration (FDA) has made substantial improvements to its inspections of foreign generic pharmaceutical manufacturers, a new report by the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) claims.

Categories: News, US, CDER, Generic drugs, Postmarket surveillance

Tags: OIG, GDUFA, FDASIA, Preapproval Inspections, Surveillance Inspections

FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data By Alexander Gaffney, RAC - Published 21 April 2015

New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards.

Categories: News, US, CDRH, Clinical, Ethics, Medical Devices

Tags: GCP, Good Clinical Practice, Guidance, Draft Guidance, FDASIA Section 1123, Clinical Data

Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies By Alexander Gaffney, RAC - Published 10 March 2015

A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Type A Meeting, Type B Meeting, Type C Meeting, PDUFA, FDASIA, Draft Guidance, Guidance

How can FDA be Improved? Patient Groups Offer Ideas By Alexander Gaffney, RAC - Published 10 December 2014

More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates.

Categories: News, US, FDA

Tags: FDASIA, Patients, Patient Groups, Patient-Centered Drug Development, FDASIA Section 917, Recommendations for FDA

FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works By Alexander Gaffney, RAC - Published 18 November 2014

The US Food and Drug Administration (FDA) has released a long-anticipated guidance document intended to explain how a new incentive program known as the Rare Pediatric Disease Priority Review Voucher system works.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: Rare Pediatric Disease Priority Review Voucher, FDASIA, Voucher, Rare Pediatric Disease Voucher, Priority Review Voucher, Guidance, Draft Guidance

FDA System to Keep Track of Drug Manufacturers Nears Completion By Alexander Gaffney, RAC - Published 05 November 2014

A new guidance published by the US Food and Drug Administration (FDA) establishes a specification by which all drug establishments will be identified under a recently established tracking system.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs, Submission and registration

Tags: UFI, Unique Facility Identification, FDASIA, Guidance, Final Guidance, DUNS, Dun and Bradstreet

Is FDA Listening Enough to Patients? Agency Wants Feedback By Alexander Gaffney, RAC - Published 03 November 2014

When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts.

Categories: News, FDA, Drugs, Medical Devices

Tags: Patient-Focused Drug Development, Patients, Patient Groups, Patient Preference Initiative, FDASIA

Manufacturer of Viagra-Laced Supplements Tried to Hide Records from FDA, Agency Claims By Alexander Gaffney, RAC - Published 09 October 2014

In one of the most unusual Warning Letters sent by the US Food and Drug Administration (FDA) this year, a dietary supplement manufacturer has been chided by regulators for allegedly failing to allow an inspector to fully inspect the facility, allegedly because the products manufactured there contained an active ingredient also contained in Pfizer's Viagra.

Categories: News, US, FDA, Audit, Compliance, Nutritional and dietary supplements

Tags: Inspection, Warning Letter, FDASIA, Adulterated

FDA Seeks Patient Insight Into Autism, Depression and 14 Other Conditions By Alexander Gaffney, RAC - Published 08 October 2014

The US Food and Drug Administration (FDA) has announced a second batch of meetings intended to facilitate the development of drugs for neglected conditions by taking into account the perspective of the patients suffering from the conditions.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Patient-Focused Drug Development, FDASIA, FDASIA Section X, Patients

FDA Outlines New Communication Process for Generic Drug Companies By Alexander Gaffney, RAC - Published 26 August 2014

The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can submit requests for information from the agency.

Categories: News, US, CDER, Generic drugs

Tags: Controlled Correspondence, Guidance, Draft Guidance, GDUFA, FDASIA

FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities By Alexander Gaffney, RAC - Published 21 August 2014

The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Medical Devices

Tags: Section 907 Report, FDASIA, Section 907, Final Guidance, Guidance, Sex, Age, Race, Minorities, Female, Women, Ethnicity

Following Criticism, FDA to Focus on Female Sexual Disorders at Upcoming Patient Meeting By Alexander Gaffney, RAC - Published 13 August 2014

The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process.

Categories: News, US, CDER, Clinical, Drugs

Tags: FSD, Female Sexual Disorder, Patient-Focused Drug Development, PFDD, FDASIA, Meeting

Medical Device User Fees Set to Drop in 2015, But Not by Much By Alexander Gaffney, RAC - Published 30 July 2014

The US Food and Drug Administration (FDA) has announced the fees it plans to charge manufacturers of medical device products in Fiscal Year (FY) 2015 under the Medical Device User Fee (MDUFA) program.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDUFA, FDASIA, Medical Device User Fee, 2015 Medical Device User Fee

FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected By Alexander Gaffney, RAC - Published 24 July 2014

The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators.

Categories: News, China, US, CDER, Active pharmaceutical ingredients, Audit, Compliance, Drugs

Tags: Import Alert, FDASIA, FDASIA Section 709, Delayed Inspection, Denied Inspection, Limited Inspection, Import Alert

ONC Director Defends Health IT Safety Center as it Struggles to Take Shape Published 21 July 2014

In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not—have.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: ONC, FDA, FDASIA, Health IT, Health IT Safety Center, Karen DeSalvo, House, Legislators, Energy & Commerce Committee

FDA Planning Five Guidance Documents to Help Children With Rare Diseases Published 10 July 2014

The US Food and Drug Administration (FDA) has released a new report indicating four core ways it plans to accelerate the development of treatments for pediatric rare diseases (PRD).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Orphan products, Research and development

Tags: PRD, Pediatric Rare Disease, Pediatric Rare Disease Voucher Program, Guidance, Report, FDASIA, FDASIA Section 510

FDA to Focus on Blood, Platelet Disorders at Upcoming Meeting With Patients By Alexander Gaffney, RAC - Published 08 July 2014

US regulators have announced they will soon hold their tenth patient-focused drug development meeting, this time focusing on a collection of blood and platelet disorders that includes hemophilia A, hemophilia B, and von Willebrand disease.

Categories: News, US, CDER, Biologics and biotechnology, Orphan products

Tags: Patient-Focused Drug Development, PFDD, FDASIA, Patients, Blood, Platelet