Search Results for Bioequivalence

Showing 1 – 25  of 34

FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

Categories: News, US, FDA, Generic drugs, Research and development

Tags: bioequivalence guidance, FDA draft guidance

US FDA Sees Major Spike in BA/BE Studies in India By Zachary Brennan - Published 19 June 2017

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs

Tags: BA and BE studies, bioequivalence, generic drugs from India

FDA Issues New and Revised Guidance for Generic Drugs By Michael Mezher - Published 16 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs.

Categories: News, US, FDA, Clinical, Generic drugs, Submission and registration

Tags: Product-Specific Guidance, Bioequivalence

House Committee Probes Restricted Distribution Systems Delaying Generics By Michael Mezher - Published 24 March 2017

The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition.

Tags: REMS, Risk Evaluation and Mitigation Strategy, Restricted Distribution, Bioequivalence Studies

FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition By Michael Mezher - Published 14 February 2017

The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Durezol, Difluprednate Ophthalmic Emulsion, Alcon, Novartis, Citizen Petition, Bioequivalence

FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers By Zachary Brennan - Published 04 October 2016

The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs).

Tags: bioequivalence studies, generic drugs, FDA draft guidance

Health Canada Updates Bioavailability Requirements for Highly Variable Drugs By Zachary Brennan - Published 18 April 2016

Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption.

Categories: News, Canada, Health Canada, Clinical, Drugs, Research and development

Tags: Health Canada, bioequivalence, highly variable drug products, bioavailability, pharmacokinetic

FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients By Zachary Brennan - Published 27 January 2016

To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs.

Categories: News, US, FDA, Active pharmaceutical ingredients, APIs, Clinical, Generic drugs, Due Diligence, Regulatory strategy, Research and development

Tags: bioequivalence studies, active ingredients, ANDAs, FDA draft guidance

Researchers Call to Modernize Bioequivalence Standards By Michael Mezher - Published 14 December 2015

A group of researchers are calling on the US Food and Drug Administration (FDA) to update generic drug regulations, warning that "outdated" bioequivalence standards threaten patient safety.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Prescription drugs, Manufacturing, Submission and registration

Tags: Bioequivalence

FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns By Zachary Brennan - Published 28 September 2015

The US Food and Drug Administration's (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments.

Categories: Clinical, Compliance, Generic drugs, Due Diligence, Government affairs, Manufacturing, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: generic drug industry, generic drug correspondence, bioequivalence clinical trials, FDA guidance

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi By Alexander Gaffney, RAC - Published 29 June 2015

A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir).

Categories: News, US, CDER, Generic drugs, Regulatory strategy

Tags: Bioequivalence, BE, ANDA, Bioequivalence Recommendations, Product-Specific BE Recommendations

FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco By Alexander Gaffney, RAC - Published 09 March 2015

The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including popular new drugs like Stendra, Belviq, Kalydeco and Brilinta.

Categories: News, US, CDER, Generic drugs

Tags: Bioequivalence

FDA to Study Quality of Long-Acting Generic Drug Products, Including Popular Birth Control Drug By Alexander Gaffney, RAC - Published 16 February 2015

The US Food and Drug Administration (FDA) is prepared to spend nearly a million dollars over the next two years to study the quality and effectiveness of long-acting generic drug products, including levonorgestrel-based birth control products, the agency announced last week.

Categories: News, US, CDER, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Manufacturing, Quality, Research and development

Tags: Long-Acting, LA, Study, Bioequivalence

India Proposes New Requirements for Bioequivalence Studies By Louise Zornoza, RegLink News - Published 22 January 2015

India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on a draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for export.

Categories: News, India, CDSCO, Clinical, Drugs

Tags: RegLink News, RegLink, Bioequivalence

EU Regulators Concerned About Drug Data Fraud by Indian Company By Alexander Gaffney, RAC - Published 08 December 2014

European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India.

Categories: News, India, Europe, EMA, Audit, Clinical, Compliance, Generic drugs, Ethics, Submission and registration

Tags: Data Integrity, GVK Biosciences, ANSM, BfArM, Bioequivalence, Data

FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta By Alexander Gaffney, RAC - Published 13 November 2014

A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta.

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

Tags: Concerta, Bioequivalence, Therapeutic Equivalence, RLD, ANDA, Orange Book

Anvisa Updates BA, BE Test Best Practices Certification By Louise Zornoza, RegLink News - Published 10 October 2014

Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies. 

Categories: News, Latin America and Caribbean, Anvisa, Compliance, Generic drugs

Tags: BA, BE, Bioavailability, Bioequivalence, Certification of Good Practice

FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs By Alexander Gaffney, RAC - Published 22 July 2014

The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.

Categories: News, US, CDER, Clinical, Generic drugs

Tags: BE, Bioequivalence, Bioequivalence Standards

Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards By Louise Zornoza, RegLink - Published 14 July 2014

Updates on the regulation of pharmaceutical products in Brazil.

Categories: News, Latin America and Caribbean, Anvisa, Drugs

Tags: Brazil, Pharmacopeia, Bioequivalence, Bioavailability

Australia’s TGA Issues Amended Bioequivalence Guidance By Louise Zornoza, RegLink - Published 10 July 2014

Australia’s Therapeutic Goods Administration (TGA) has issued an amended bioequivalence guidance document applicable to all prescription medicines except for biologicals. 

Categories: News, Oceania, TGA, Drugs

Tags: Bioequivalence, Guidance

FDA Formally Withdraws Approval for Second Generic Version of Popular Antidepressant By Alexander Gaffney, RAC - Published 11 April 2014

Categories: US, FDA

Tags: Wellbutrin XL, Bupropion, Generic Drug, Budeprion, Latest News, pharmaceutical, bioequivalence, drug

FDA Clears Way for Generics of 26 Popular Drugs By Alexander Gaffney, RAC - Published 03 April 2014

Categories: US, FDA, CDER

Tags: BE Recommendations, Generic Drug, BE, OGD, Latest News, pharmaceutical, bioequivalence, drug

Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs By Alexander Gaffney, RAC - Published 17 March 2014

Categories: US, FDA

Tags: NDA Supplement, BA/BE, Regulatory Explainer, BA, Bioavailability, BE, IND, Latest News, pharmaceutical, bioequivalence, draft guidance, NDA

India’s CDSCO Says Bioequivalence Testing Centers Require Approval By Louise Zornoza, RegLink - Published 09 January 2014

Categories: Regulatory Update, India, CDSCO

Tags: BA, Bioavailability, BE, bioequivalence

FDA Updates Bioequivalence Testing Guidance Intended for Generic Drug Manufacturers By Alexander Gaffney, RF News Editor - Published 04 December 2013

Categories: US, FDA

Tags: Generic Drug, BE, ANDA, Latest News, pharmaceutical, bioequivalence, draft guidance, drug