Search Results for Final Guidance

Showing 1 – 25  of 60

FDA Finalizes Combination Product Classification Guidance By Michael Mezher - Published 26 September 2017

The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices

Tags: Combination Products, Request for Designation, RFD, Classification, Final Guidance

FDA, HHS Finalize Guidance on Documenting IRB Activities By Michael Mezher - Published 25 September 2017

The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities.

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

Tags: Institutional Review Board, IRB, Minutes, Final Guidance

FDA Finalizes Guidance on Deviation Reporting for HCT/Ps By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue

Tags: HCT/Ps, human tissues, FDA final guidance

FDA Finalizes Guidance on Benefit-Risk Considerations for IDEs By Michael Mezher - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing its framework for assessing the benefits and risks of investigational device exemptions (IDEs).

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

Tags: Investigational Device Exemption, Final Guidance

FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems Published 07 October 2016

The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users.  

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

Tags: blood glucose monitoring, FDA final guidance, glucose monitoring systems

FDA Finalizes Guidance on Microbiology Data for Antibacterials By Michael Mezher - Published 29 August 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs.

Categories: News, US, FDA, Clinical, Drugs, Preclinical, Research and development

Tags: Antibacterial, Antimicrobial resistance, Microbiology data, Final guidance

GPhA Questions Legality of FDA Guidance on Physical Attributes of Generic Drugs By Zachary Brennan - Published 14 September 2015

The Generic Pharmaceutical Association (GPhA) is raising a number of concerns, among them the legality, of the US Food and Drug Administration's (FDA) recently issued final guidance on the size, shape and other physical attributes of generic drugs.

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

Tags: GPhA, FDA guidance, generic drugs, physical attributes of generic drugs, FDA final guidance

FDA Finalizes Guidance on Overfilling Injectable Vials By Alexander Gaffney, RAC - Published 24 June 2015

New guidance just issued by the US Food and Drug Administration (FDA) calls on pharmaceutical and biopharmaceutical companies to more closely control the amount of excess product contained in vials of injectable drugs and biologics.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs

Tags: Vials, Guidance, Final Guidance, Overfill

Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says By Alexander Gaffney, RAC - Published 18 June 2015

The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference.

Categories: News, US, CDER, Generic drugs, Prescription drugs, Submission and registration

Tags: Guidance, Final Guidance, RLD, Tablest, Capsules, Size, Shape, Color, Taste

FDA Finalizes New Approach on Naming Drugs Containing Salt Drug Substances By Alexander Gaffney, RAC - Published 16 June 2015

The US Food and Drug Administration (FDA) has finalized a new policy detailing how manufacturers of drug products containing salts should name their products.

Categories: News, US, CDER, Drugs, Labeling

Tags: USP, Guidance, Final Guidance, Naming, Monograph

FDA Publishes New Guidance on Common Biosimilarity Questions By Alexander Gaffney, RAC - Published 12 May 2015

A newly revised guidance document published by the US Food and Drug Administration (FDA) provides additional insight into how the agency plans to regulate biosimilar products.

Categories: News, US, CDER, Biologics and biotechnology

Tags: Biosimilar, Guidance, Final Guidance, Biosimilarity

After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity By Alexander Gaffney, RAC - Published 28 April 2015

The US Food and Drug Administration (FDA) today finalized three long-sought guidance documents outlining its expectations for near-exact copies of existing biological drugs known as biosimilars.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Quality, Submission and registration

Tags: Biosimilars, Guidance, Final Guidance, Biosimilarity

FDA Willing to Accept Different Endpoints When Assessing Lung Cancer Drugs By Alexander Gaffney, RAC - Published 22 April 2015

Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week.

Categories: News, US, CDER, Clinical, Drugs

Tags: NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, Final Guidance, Guidance, Endpoints

New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices By Alexander Gaffney, RAC - Published 09 April 2015

The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions.

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

Tags: EAP, Expedited Access Pathway, Expedited Access Program, Guidance, Final Guidance, Expedited Access Premarket Approval, EAP Designation

FDA Explains how Companies can Modify a Drug Safety Assurance Plan By Alexander Gaffney, RAC - Published 06 April 2015

A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling, Postmarket surveillance

Tags: REMS, Guidance, Final Guidance, Risk Evaluation and Mitigation Strategies, Prior Approval Supplement, CBE, Changes Being Effects, PAS

FDA Finalizes Approach to Abuse-Deterrent Opioids By Alexander Gaffney, RAC - Published 01 April 2015

Federal regulators have at long last finalized a policy which establishes voluntary guidelines by which manufacturers of opioid-based painkillers can prove that their products are resistant to misuse and abuse by patients.

Categories: News, US, CDER, Clinical, Drugs, Labeling, Postmarket surveillance

Tags: Opioids, Abuse-Deterrent Opioids, Guidance, Final Guidance

FDA Considers Relaxing Clinical Testing Requirements for Some Biotherapeutic Products By Alexander Gaffney, RAC - Published 31 March 2015

The US Food and Drug Administration (FDA) is considering making it easier for companies to test certain "live biotherapeutic products" like probiotics in early-stage trials, the agency has announced.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Manufacturing, Nutritional and dietary supplements

Tags: Guidance, Final Guidance, LBPs, Live Biotherapeutic Products, Dietary Supplement

Breaking Down Barriers to Drug Innovation a Team Effort, FDA Says in Guidance By Alexander Gaffney, RAC - Published 30 March 2015

A new guidance document just finalized by the US Food and Drug Administration (FDA) aims to clarify how pharmaceutical companies and the public can help accelerate drug development through the agency's Critical Path Initiative (CPI).

Categories: News, US, FDA, Clinical, Drugs

Tags: Guidance, Final Guidance, CPI, Critical Path Initiative, Drug Innovation, Innovation, Critical Path Innovation Meetings

Are Biotechnology Products Safe for the Environment? FDA's New Policy Asks for Data By Alexander Gaffney, RAC - Published 23 March 2015

While the US Food and Drug Administration (FDA) may be primarily concerned with what medicinal products do to the human body, a lesser-known secondary concern of regulators is what a product will do to the environment.

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

Tags: Guidance, Final Guidance, GTVV, gene therapies, vectored vaccines, related recombinant viral products, related recombinant microbial products

FDA Finalizes Lot Distribution Report Guidance With Few Changes By Alexander Gaffney, RAC - Published 20 March 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called "lot distribution reports" (LDRs)—reports detailing the quantity of a product which has been legally distributed.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Postmarket surveillance

Tags: Guidance, Final Guidance, LDR, Lot Distribution Reports, BLA

Legal Analysis: FDA 'Pet Peeves' Could Lead to Bans on Drug Companies By Alexander Gaffney, RAC - Published 17 March 2015

In 2012, the US Food and Drug Administration (FDA) was granted new authority to go after pharmaceutical companies that were, in its opinion, preventing regulators from fully inspecting drug and device manufacturing facilities. If a company way "delaying, denying, limiting or refusing" an FDA inspection, the law stated, FDA could deem a drug to be adulterated and prevent it from being sold.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Drugs, Regulatory strategy

Tags: Guidance, Final Guidance, Delay, Deny, Inspection

New FDA Guidance Clears a Path for Urinary Infection Drugs of the Future By Alexander Gaffney, RAC - Published 16 February 2015

US healthcare product regulators have finalized a new policy set to make it easier for pharmaceutical companies to develop drugs to treat complicated urinary tract infections (cUTIs).

Categories: News, US, CDER, Clinical, Drugs

Tags: UTI, cUTI, Complicated Urinary Tract Infection, Urinary Tract Infection, Guidance, Final Guidance

Citing Safety Risks, FDA Adopts New Standards for Small-Bore Connectors By Alexander Gaffney, RAC - Published 12 February 2015

Even small devices can cause big problems. That's the conclusion of a new guidance document issued this week by the US Food and Drug Administration (FDA), which is trying to make "small-bore connectors" safer.

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

Tags: Small-Bore Connectors, Enteral Connectors, Luer Locks, AAMI, Guidance, Final Guidance

28 Days Later: FDA's Clinical Endpoint to Stop the Horror of Complicated Abdominal Infections By Alexander Gaffney, RAC - Published 10 February 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to make it easier for pharmaceutical companies to develop drugs to treat "complicated" intra-abdominal infections (cIAIs), with a goal of achieving a successful outcome within 28 days of a patient starting treatment.

Categories: News, US, CDER, Clinical, Drugs

Tags: Guidance, Final Guidance, cIAIs, Complicated Intra-Abdominal Infections

FDA Confirms it Won't Regulate Apps or Devices Which Store Patient Data By Alexander Gaffney, RAC - Published 06 February 2015

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy which explains how it plans to regulate medical devices, including mobile apps, which track patient data and store patient images.

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

Tags: Mobile Medical Apps, FDA Mobile Apps, MDDS, MIDS, Medical Software, Guidance, Final Guidance