Search Results for Draft Guidance

Showing 1 – 25  of 256

Meeting With FDA After a CRL: Draft Guidance on What to Expect By Zachary Brennan - Published 13 October 2017

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify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Tags: CRL, complete response letter, draft guidance

PDUFA VI: FDA Explains User Fee Changes in Draft Guidance By Zachary Brennan - Published 12 October 2017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(FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.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Tags: PDUFA VI, prescription drug user fees, draft guidance

When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance By Zachary Brennan - Published 12 October 2017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and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.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Tags: 505(b)(2) application, ANDA, FDA draft guidance

REMS Format and Content: FDA Offers Draft Guidance By Zachary Brennan - Published 11 October 2017

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.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Tags: REMS, REMS document, FDA draft guidance, GDUFA II

Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements By Zachary Brennan - Published 10 October 2017

Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers.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 Targets Complex Generic Drugs With New Draft Guidance By Zachary Brennan - Published 02 October 2017

The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Submission and registration

Tags: generic drugs, complex generic drugs, FDA draft guidance

Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable' By Zachary Brennan - Published 22 September 2017

A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster reviews for generic drugs.

Categories: News, US, FDA, Generic drugs, Government affairs, Manufacturing

Tags: Pre-submission facility guidance, FDA draft guidance, priority generic drug reviews

FDA Offers Draft Guidance on Organ Preservation Device Animal Studies By Zachary Brennan - Published 15 September 2017

As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices.

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

Tags: organ preservation, FDA draft guidance

FDA Steps in to Regulate Microneedling Devices By Michael Mezher - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation.

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

Tags: Microneedling, Micro-needling, Draft Guidance

Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance By Zachary Brennan - Published 12 September 2017

The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs.

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

Tags: radiopharmaceuticals, nonclinical recommendations, FDA draft guidance

FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug By Zachary Brennan - Published 29 August 2017

Manufacturers looking to market generic versions of a heart medicine that has been around since the 18th century and seen its price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday.

Categories: News, US, FDA, Compliance, Generic drugs

Tags: digoxin, generic draft guidance, Concordia Pharmaceuticals

FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics By Zachary Brennan - Published 08 August 2017

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Postmarket surveillance

Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance

Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance By Zachary Brennan - Published 08 August 2017

With an increased demand for the repackaging of solid oral dosage form drugs into unit-dose containers, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.

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

Tags: expiration date, FDA draft guidance, repackaging

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

FDA Delays Enforcement of Product Identifier Requirements By Zachary Brennan - Published 30 June 2017

In a draft guidance published Friday, the US Food and Drug Administration (FDA) says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: DSCSA, track and trace, FDA draft guidance

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability By Zachary Brennan - Published 04 May 2017

The nonprofit industry group Biosimilars Forum is calling on the US Food and Drug Administration (FDA) to clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs

Tags: biosimilars, FDA draft guidance, Biosimilars Forum

Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration By Zachary Brennan - Published 11 April 2017

For an agency that has announced its intention to release more than 100 draft guidance documents in 2017, the US Food and Drug Administration (FDA) is off to a slow start following President Donald Trump’s inauguration.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA guidance documents, OMB, draft guidance pharmaceuticals

FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity By Zachary Brennan - Published 04 April 2017

As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Submission and registration

Tags: interchangeable biosimilars, interchangeability, FDA draft guidance, comments on FDA guidance

FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients By Michael Mezher - Published 23 March 2017

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

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

Tags: Delayed Graft Function, DGF, Draft Guidance

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance By Zachary Brennan - Published 03 January 2017

Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information are coming to an end, possibly as soon as 2019.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Manufacturing

Tags: pharmaceutical manufacturing, draft guidance, manufacturing information

CDRH Lays Out Guidance Plans for FY 2017 By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017.

Categories: News, US, CDRH, Clinical, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CDRH, draft guidance for medical devices, device manufacturer guidance from FDA