Results 90 found
September 28th, 2017
PRE-RECORDED WEBINAR: Writing HFE Reports for Submission to FDA

Since the late 1990s, FDA has expected Class II and III medical device manufacturers to apply human factors engineering (HFE) comprehensively to help reduce the chance of harm due to use errors. In 2016, FDA updated its HFE guidance to industry, specifying that submissions should include an HFE Report if the associated device requires users… read more

December 14th, 2016
FDA Announces Request for Information on the Appropriate Product Category and Reference Amount of Nut Butter Spreads

FDA Announces Request for Information on the Appropriate Product Category and Reference Amount of Nut Butter Spreads Landing Copy: The US Food and Drug Administration (FDA) has announced a request for information regarding the appropriate reference amount customarily consumed (RACC) and the product category for certain food products. Specifically, the request for information applies to… read more

December 14th, 2016
FDA Amends Food Additive Regulation for the Use of PFCs in Food Packaging

The US Food and Drug Administration (FDA) has amended the Food Additive Regulation involving the use of long-chain perfluorinated compounds (PFCs) used in “grease-proof” food packaging. The amendment decides to no longer authorize the use of long-chain PFCs for specific food-contact uses such as coatings on fast-food wrappers, to-go boxes, and pizza boxes. The decision… read more

December 14th, 2016
FDA Releases Final Rule for the Uniform Compliance Date for Food Labeling Regulations

The US Food and Drug Administration (FDA) has released the final rule for the Uniform Compliance Date for Food Labeling Regulations. This final rule specifies that January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. This final rule was effective starting… read more

December 13th, 2016
FDA Releases Revised Guidelines on the Submission of Equivalence Evidence of Pharmaceutical Products

Philippine Food and Drug Administration (FDA) has released the ‘Revised Guidelines on the Submission of Equivalence Evidence for Registration of Pharmaceutical Products.’ The document establishes requirements for the submission of in vitro or in vivo equivalence evidence for the registration of the following pharmaceutical products: Traditional/herbal medicines Biological products Medical oxygen Veterinary drugs Stem cell… read more

December 13th, 2016
FDA Finalizes Rule on Over-the-Counter Time and Extent Applications of Drugs

The US Food and Drug Administration (FDA) has finalized the rule on over-the-counter time and extent applications of drugs. Specifically, FDA amends the nonprescription (over-the-counter or OTC) drug regulations The final rule specifies the time and extent application (TEA) process for OTC drugs. This final rule establishes the timelines and performance metrics for FDA’s review… read more

November 7th, 2016
US Congress Introduces Bill Banning BPA in Food Containers

US Senator Edward J. Markey along with Congresswoman Grace Meng and Congressman Ted W. Lieu introduced H.R.6269 – Ban Poisonous Additives Act of 2016 on September 28, 2016. The bill aims to ban the use of bisphenol A (BPA, CAS 80-05-7) in food containers, and for other purposes. The bill also states that a warning… read more

November 7th, 2016
FDA Consults on the Notice Released for Dietary Supplements

The US Food and Drug Administration (FDA) is consulting the public on the release of the notice intended for dietary supplements. This notice is entitled as Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. The notice implies the need to publish… read more

November 7th, 2016
FDA Releases Warning on the Use of Homeopathic Teething Tablets and Gels

The US Food and Drug Administration (FDA) has released a warning concerning the use of homeopathic teething tablets and gels. These products are identified to pose a risk to infants and children. FDA advises to stop and dispose the use of these products immediately. Use of these products may result to the following medical conditions… read more

October 19th, 2016
Webinar: Impact of the New FDA Guidance on 3D Printed Medical Devices

The recording of the recent UL AM and UL Health Services webinar, Impact of the New FDA Guidance on 3D Printed Medical Devices, is now available. The US FDA recently released a draft guidance document for medical device manufacturers working with additive manufacturing (AM). According to FDA, the draft guidance is meant to provide manufacturers… read more