FDA Policy/General
FDA, in conjunction with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, has released the National Antimicrobial Resistance Monitoring System (NARMS) Integrated Summary 2019. An FDA statement says the summary combines antimicrobial resistance data in bacteria isolated from
FDA Policy/General
A new Government Accountability Office (GAO) report recommends that FDA and other HHS agencies develop procedures for reporting and addressing allegations of political interference and train staff on how to report such allegations. It found that FDA officials did not identify any formally reported internal allegations of political interference in
FDA Policy/General
Federal Register notice: FDA has announced a 5/18-19 meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) Advisory Committee. On 5/18, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. On 5/19,
FDA Policy/General
Two Arnall Golden Gregory attorneys say that drug companies that want the benefits of specific messaging must assume the risks of that messaging. Commenting on a CDER Office of Prescription Drug Promotion untitled letter to Bausch Health Companies about the promotion of its Duobril (halobetasol propionate and tazarotene) topical lotion,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry #106 entitled The Use of Published Literature in Support of New Animal Drug Applications. The document discusses multiple uses of the scientific literature, including narrative reviews, systematic reviews, and meta-analyses to support approval of a new animal
FDA Policy/General
Federal Register notice: FDA is correcting a 2/28 notice announcing the withdrawal of approval of five ANDAs from multiple applicants. The notice indicated that FDA was withdrawing approval of a Jiangsu Hengrui Pharmaceuticals ANDA for gabapentin capsules. The company has since notified the agency that it does not want
FDA Policy/General
Federal Register notice: FDA is permanently debarring Yvelice Villaman-Bencosme from providing services in any capacity to a person that has an approved or pending drug product application. The agency says that as a licensed medical doctor who served as a clinical investigator at Unlimited Medical Research, Villaman-Bencosme conspired
FDA Policy/General
Federal Register notice: FDA is revoking the emergency use authorizations issued to BillionToOne, Inc. for the qSanger-Covid–19 Assay, RTA Laboratories Biological Products Pharmaceutical and Machinery Industry for the Diagnovital SARS–CoV–2 Real-Time PCR Kit, DiaSorin Inc. for the DiaSorin Liaison SARS–CoV–2 IgM Assay, and
FDA Policy/General
BioDelivery Sciences International has entered into an agreement with Endo Pharmaceuticals to terminate Endo’s licensing rights for pain drug Belbuca (buprenorphine) buccal film. As a result of the agreement, the world-wide rights to Belbuca will be transferred back to BioDelivery Sciences on undisclosed terms. Annual sales for the
FDA Policy/General
DEVICES FDA has approved a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems. The test enables donor screening laboratories to “apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness” (OMB Control Number 0910-0876). The agency says that occasionally it will need to communicate with consumers and other stakeholders about immediate health issues which could affect public
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs — General Considerations. The document provides recommendations to sponsors planning to include bioavailability information in INDs, NDAs and supplemental NDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet. The document addresses agency recommendations regarding clinical trials for such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. The document is intended to assist ANDA applicants seeking approval of a drug that is qualitatively different or quantitatively different from
FDA Policy/General
Federal Register notice: FDA is making available a final guidance on Compounding Animal Drugs from Bulk Drug Substances. The document describes FDA’s current thinking about such compounding, identifies the agency’s enforcement priorities, and describes circumstances under which FDA generally does not intend to take action against veterinarians or
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. The document offers recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to enroll adequate
FDA Policy/General
A California state appeals court has upheld almost all of a massive $344 million civil penalty judgment against Johnson & Johnson’s Ethicon unit awarded in a bench trial for circulating misleading instructions about its transvaginal pelvic mesh products. Legal Newsline reports the appeals court only struck $42 million in
FDA Policy/General
Federal Register notice: FDA has announced a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss two bluebird bio BLAs: (1) a BLA for elivaldogene autotemcel for treating patients younger than 18 years of age with early cerebral adrenoleukodystrophy who do not
FDA Policy/General
Federal Register notice: FDA has made available two final device-specific guidance documents for the Safety and Performance Based Pathway. One is on Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway, and the other is on Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway.
FDA Policy/General
Federal Register notice: FDA is permanently debarring Lisett Raventos from providing services in any capacity related to an approved or pending drug product application. FDA bases the debarment on its finding that she was convicted of a felony under federal law for conduct relating to a drug product’s development.
FDA Policy/General
FDA has published a final guidance, Compounding Animal Drugs from Bulk Drug Substances, describing the agency’s enforcement policy for the compounding of animal drugs from bulk substances by or under the direction of veterinarians or pharmacists. The document does not apply to animal drugs compounded for use in investigations
FDA Policy/General
Pro golfer James Hahn has signed on with IBSA Pharma to promote Licart (diclofenac epolamine), the company’s newest topical pain product. A company statement says Licart is the first and only once-a-day topical non-steroidal anti-inflammatory drug indicated to treat acute pain due to minor strains,