Search Results for BE Studies

Showing 1 – 25  of 57

Drugged Driving: FDA Finalizes Study Guidance By Michael Mezher - Published 08 November 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on how drugmakers should study the effects of their drugs on driving ability.

Categories: News, US, FDA, Clinical, Drugs, Preclinical

Tags: Driving, Driving Studies, Final Guidance

Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies By Michael Mezher - Published 06 October 2017

The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases.

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

Tags: Natural History Studies, Rare Diseases, Orphan Drugs, Grants

Bioequivalence Studies of Solid Oral Dosage Forms Overview By Sharry Arora - Published 16 August 2017

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs

Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability

Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials By Michael Mezher - Published 04 August 2017

In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making.

Categories: News, Biologics and biotechnology, Clinical, Drugs

Tags: Randomized Controlled Trials, RCTs, Observational Studies

EMA Updates Guidance on Three Post-Authorisation Activities By Michael Mezher - Published 14 July 2017

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Quality, Submission and registration

Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation

Fears Over Device Surveillance Amid Talk of Deregulation By Michael Mezher - Published 30 June 2017

A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Power Morcellators, Postmarketing Studies, Postmarket Surveillance, NEST

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 Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biomarker qualification, FDA case studies, biomarkers, drug development

Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds By Zachary Brennan - Published 09 May 2017

Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: adverse events, significant safety events, postmarket studies

FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds By Zachary Brennan - Published 08 May 2017

For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Research and development

Tags: surrogate markers, clinical endpoints, postapproval studies

Are Biosimilars 'Interchangeable' in the EU? A New Perspective By Zachary Brennan - Published 31 March 2017

The EU’s take on the class of medicines known as biosimilars is a slight variation of what is seen in the US, with the US creating two distinct types: Follow-on biologics that are biosimilar, or "expected to produce the same clinical result as the reference product," and ones that are "interchangeable," or able to be switched with their reference product.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology

Tags: interchangeable biosimilars, interchangeability, switching studies, biosimilar

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

EMA Touts Growth of Post-Authorisation Study Database By Michael Mezher - Published 13 February 2017

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Post-Authorisation Studies, PAS, EU PAS Register

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations By Zachary Brennan - Published 26 January 2017

A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies.

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

Tags: Pfizer, Novartis, Celgene, GLP for nonclinical lab studies, FDA proposed rules

FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry on 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations.

Categories: News, US, FDA, Active pharmaceutical ingredients

Tags: BE studies, generic drug guidance from FDA, active ingredients

FDA Revises Guidance on Safety Testing of Drug Metabolites By Zachary Brennan - Published 22 November 2016

The US Food and Drug Administration (FDA) on Tuesday released revised guidance on recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Preclinical

Tags: drug metabolites, safety testing, nonclinical drug studies

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

FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies.

Categories: News, US, FDA, Clinical, Drugs, Due Diligence, Medical Devices, Preclinical

Tags: GLP regulations, nonclinical studies, quality inspections, FDA proposed rules

FDA Issues New Guidance on Osteoporosis Drug Development By Michael Mezher - Published 13 June 2016

The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Preclinical, Regulatory strategy

Tags: Osteoporosis, Animal studies, Bone quality

FDA Draft Guidance to Assist CMS With IDE Coverage Decisions By Michael Mezher - Published 31 May 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS).

Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement

Tags: CMS, Reimbursement, Investigational Device Exemption, IDE, Early feasibility studies, EFS, Category A, Category B, Medicare

FDA Finalizes Guidance on Postmarket Device Surveillance By Zachary Brennan - Published 13 May 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices.

Categories: News, US, CDRH, Clinical, Medical Devices, Postmarket surveillance

Tags: medical device postmarket studies, device surveillance, postmarket med dev studies, 522 order

On Eliminating Two-Year Rat Carcinogenicity Studies for Pharma: ICH Seeks More Data By Zachary Brennan - Published 12 April 2016

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will continue to study for two more years whether guidance can be revised on certain situations when sponsors will not have to conduct and submit a two-year rat carcinogenicity study for a developing drug.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, ICH, MHLW, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Preclinical

Tags: ICH, S1 Guidance, rat carcinogenicity studies, pharmaceutical studies

Transparency: What FDA Drug, Device Regulations are Coming Later in 2016 By Zachary Brennan - Published 28 March 2016

As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA rules, FDA proposed rules, postmarketing studies of combo products, device labels, compounding drugs, OTC cold medicines

FDA Shares Views on Juvenile Animal Studies for Oncology Drugs By Michael Mezher - Published 25 March 2016

In a recently published article, officials from the US Food and Drug Administration (FDA) say that studies comparing the effects of drugs in juvenile animal populations against their effects in adult animals are generally not useful in guiding pediatric clinical development, especially if such studies delay the launch of a clinical trial.

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

Tags: Juvenile animal studies, pediatric trials, Richard Pazdur

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