Tag: Guidance

FDA Finalized Guidance on Adaptive Clinical Trial Designs for Drugs and Biologics

clinical-trial-material
The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics. The 33-page guidance, which finalizes a draft version released for...

FDA Prepared Guidance on Device Export Certificate Denials

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The US Food and Drug Administration (FDA) finalized guidance explaining how the agency handles denials of requests for a certificate to a foreign government (CFG) for medical devices and how to reques...

FDA Published Recommendations on Breast Implant Labeling

The US Food and Drug Administration (FDA) is taking another significant step in protecting women’s health by helping to ensure patients have complete information about the benefits and risks of breast...

FDA Issued Guidances with Recommendations for Performance Tests and Labeling for Guidewires

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The US Food and Drug Administration (FDA) issued two final guidances laying out recommendations for performance tests and labeling for guidewires intended for use in the coronary, peripheral and neuro...

EMA Released MDR Guidance which Addresses Transitional Provisions

European-Commission
The European Commission’s Medical Device Coordination Group (MDCG) released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued i...

FDA Finalized Guidance on Nonclinical Studies for Enzyme Replacement Therapies

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The US Food and Drug Administration (FDA) finalized guidance to help sponsors design and conduct nonclinical studies for developing investigational enzyme replacement therapy (ERT) products. ERT pr...

FDA Release Guidances on Advancement of Digital Health Policies

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The U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools and to ensure the agency’s approach to ove...

FDA to Delay Enforcing Provision of Drug Supply Chain Security Act

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The US Food and Drug Administration (FDA) issued final guidance explaining that it will delay enforcing a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesale distribut...

EAEU New Laboratory Tests Guidelines Presented

laboratory
On September 13, 2019, on the EAEU legal portal docs.eaeunion.org published Recommendation of the EEC Board No. 28 “On the Guidelines for Determining the Scope of Laboratory Tests in the Examination o...

FDA Released Draft Guidance on New Safer Technologies Program

The US Food and Drug Administration (FDA) released draft guidance to introduce a new, voluntary program for certain medical devices and device-led combination products that are expected to improve the...

FDA Finalized Guidance on Citizen Petitions

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The US Food and Drug Administration (FDA) finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a...

FDA Finalized Guidance on Humanitarian Device Exemption Program

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The US Food and Drug Administration (FDA) on Thursday finalized guidance on the Humanitarian Device Exemption (HDE) program, reflecting changes made by the 21st Century Cures Act and further explainin...

EMA Published Two Guidances on Drug Shortages

Regulators in the European Union have taken the first steps to diminish shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two gui...

Draft ICH Guideline on Clinical Trials Discussed at EMA

clinical-trials
The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical...

EMA Offered Comments and Edits on FDA Draft Guidance on Biosimilars

biosimilars
Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late last month offered line-by-line comments and edits on a recently released dra...

NICE Published Draft Guidance Recommending Neratinib for People with Early Breast Cancer

cancer treatment
NICE has published draft guidance recommending neratinib as an additional treatment for some people with early hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-posi...