Search Results for Guidance

Showing 1 – 25  of 611

FDA Unveils Plan for CDER Draft Guidance in 2018 By Zachary Brennan - Published 19 January 2018

The plan for 2018 guidance documents from the US Food and Drug Administration (FDA) includes more than 10 guidance documents designated under several categories, including FDA procedures, pharmaceutical quality/chemistry, manufacturing and controls (CMC) and clinical/medical.

Categories: News, US, CDER, Drugs

Tags: draft guidance

Hormonal Contraceptive Labeling: FDA Issues Draft Guidance By Michael Mezher - Published 03 January 2018

The US Food and Drug Administration (FDA) on Tuesday issued new draft guidance providing labeling recommendations for hormonal contraceptives in line with requirements from the agency's 2006 physician labeling rule (PLR) and 2014 pregnancy and lactation labeling rule (PLLR).

Categories: News, US, FDA, Drugs, Labeling

Tags: Combined Hormonal Contraceptives, CHC, Oral Contraceptives, Draft Guidance

FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP By Zachary Brennan - Published 03 January 2018

Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.

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

Tags: ANDA review cycles, generic drug guidance, MAPP

Best Practices for IND Sponsor Communications: FDA Finalizes Guidance By Zachary Brennan - Published 02 January 2018

The US Food and Drug Administration (FDA) last week finalized guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and FDA.

Categories: News, US, FDA, Drugs, Government affairs, Research and development

Tags: IND sponsor communications, FDA guidance, PDUFA

CMC Changes for Biologics: FDA Offers Draft Guidance By Zachary Brennan - Published 21 December 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA).

Categories: News, US, CBER, Biologics and biotechnology, Manufacturing

Tags: FDA draft guidance, CMC changes

Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance By Zachary Brennan - Published 20 December 2017

Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors.

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

Tags: ANDA formal meetings, FDA draft guidance, SOCMA, Teva, Sanofi

FDA Plots New Enforcement Approach for Homeopathic Products By Zachary Brennan - Published 18 December 2017

The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic.

Categories: News, FDA, Compliance, Crisis management, Nutritional and dietary supplements, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: homeopathic, FDA enforcement, FDA draft guidance

Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics By Michael Mezher - Published 18 December 2017

The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology.

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

Tags: Nanomaterials, Nanotechnology, Draft Guidance

Successful Human Factors Programs: Key Considerations from a Regulator's Perspective By Melissa R. Lemke - Published 12 December 2017

This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the division of anesthesiology, general hospital, respiratory, infection control, and dental devices.

Categories: Features, US, FDA, Medical Devices, Research and development

Tags: Human Factors Engineering, HFE, Guidance

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

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