Search Results for Guidance

Showing 1 – 25  of 602

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse to file, NDA, BLA, FDA draft guidance

FDA Finalizes Guidance on Promotional Drug Labeling and Ads By Zachary Brennan - Published 11 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More By Zachary Brennan - Published 11 December 2017

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: CDRH guidance, 510(k) alternative pathway, PMA

Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance By Zachary Brennan - Published 08 December 2017

The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments.

Categories: News, US, FDA, Generic drugs

Tags: ANDA amendments, FDA draft guidance

More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

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

Tags: rare pediatric disease, Gaucher, FDA draft guidance

FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi, a parasite that causes Chagas Disease, in blood and blood components.

Categories: News, US, CBER, Blood, Compliance

Tags: Chagas Disease, blood collection, FDA guidance

3D Printing: FDA Finalizes Guidance for Medical Devices By Michael Mezher - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

Categories: News, US, FDA, Manufacturing, Medical Devices

Tags: 3D Printing, Additive Manufacturing, Final Guidance

FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices By Zachary Brennan - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMS coverage of medical devices, FDA guidance

Evaluating Analytical Similarity: Stakeholders Raise Questions With FDA Draft Guidance By Zachary Brennan - Published 04 December 2017

Biopharma companies and industry groups, including Pfizer, Genentech, Boehringer Ingelheim and the Biosimilars Council, have raised detailed questions in recently released comments on the US Food and Drug Administration’s (FDA) draft guidance on statistical approaches to evaluate analytical similarities for biosimilars.

Categories: News, US, FDA, Biologics and biotechnology, Regulatory intelligence, Regulatory strategy

Tags: biosimilar guidance, analytical similarity

FDA Unveils New Regenerative Medicine Framework By Zachary Brennan - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday launched a new policy framework for regenerative medicine, building off a previous framework from 2005, as part of efforts to bring new cell, stem cell and tissue products to patients as efficiently as possible while managing the proliferation of unscrupulous actors hawking unproven therapies.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regenerative medicine, RMAT, FDA guidance

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

FDA Finalizes Guidance on Developing DAA Drugs to Treat Hepatitis C Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday finalized draft guidance on developing direct-acting antiviral (DAA) drugs to treat Hepatitis C after revising the guidance twice.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: DAA drugs, Hepatitis C, FDA guidance

De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014 By Zachary Brennan - Published 27 October 2017

Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: de novo request, FDA guidance, de novo device

FDA Issues Disease-Specific Draft Guidance for Pediatric GERD By Michael Mezher - Published 26 October 2017

The US Food and Drug Administration (FDA) on Thursday issued draft guidance detailing clinical considerations for drugmakers looking to develop products to treat pediatric gastroesophageal reflux disease (GERD).

Categories: News, FDA, Clinical, Drugs

Tags: Gastroesophageal Reflux Disease, GERD, Pediatric Drug Development, Draft Guidance

FDA Offers Two Draft Guidances on Drug-Drug Interactions By Zachary Brennan - Published 25 October 2017

The US Food and Drug Administration (FDA) on Wednesday released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs).

Categories: News, US, FDA, Compliance, Drugs, Research and development

Tags: drug-drug interactions, FDA draft guidance, in vitro metabolism

When to Submit a New 510(k): FDA Finalizes Guidance By Michael Mezher - Published 24 October 2017

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software.

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

Tags: 510(k), 510(k) change guidance

Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars By Zachary Brennan - Published 24 October 2017

Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.

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

Tags: FDA draft guidance, biosimilars, Sandoz

Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents By Zachary Brennan - Published 19 October 2017

The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

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

Tags: FDA guidance, product-specific guidance, generic drug guidance

Meeting With FDA After a CRL: Draft Guidance on What to Expect By Zachary Brennan - Published 13 October 2017

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CRL, complete response letter, draft guidance

PDUFA VI: FDA Explains User Fee Changes in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: PDUFA VI, prescription drug user fees, draft guidance

When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: 505(b)(2) application, ANDA, FDA draft guidance

REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

Categories: News, US, FDA, Drugs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: REMS, REMS document, FDA draft guidance, GDUFA II

Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements By Zachary Brennan - Published 10 October 2017

Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers.

Categories: News, US, FDA, Drugs, Labeling, Packaging

Tags: child-resistant packaging, Boehringer Ingelheim, FDA draft guidance

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

Categories: News, Canada, Europe, US, FDA, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, common technical document, ICH guidance

FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo