FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases — Questions and Answers (Revision 1).” The document is intended to provide necessary updates to the final guidance entitled “Antibacterial Therapies for Patients With
Drugs
More Product-specific Bioequivalence Guides 05/20/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on, among other things, bioequivalence study design to support ANDA submissions. To view the notice, click here. Science Board to Discuss
Drugs
DEVICES BioArchitects has gained FDA clearance to introduce its titanium patient specific cranial/craniofacial implants. The company says the plates are printed on Arcam AB‘s additive manufacturing 3D printers that use electron beam melting technology designed using CAD based on patient CT or MRI scans. FDA has cleared a
FDA Policy/General
Shire has agreed to sell its oncology business for $2.4 billion to Servier. The transaction includes in-market products Oncaspar (pegaspargase), a component of multi-agent treatment for acute lymphoblastic leukemia (ALL) and outside-the-U.S. rights to Onivyde (irinotecan pegylated liposomal formulation), a component of multi-agent
Drugs
Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) have reintroduced the bipartisan Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act to make prescription drugs more affordable and accessible for Americans across the nation. The measure aims to “addresses one of Big Pharma’s most effective
Drugs
FDA has placed a partial clinical hold on a Foghorn Therapeutics Phase 1 dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The hold follows a report on the recent death of a subject with potential differentiation syndrome, which is associated
Drugs
Federal Register notice: FDA is withdrawing approval of 21 ANDAs from multiple applicants after they notified the agency that the products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on, among other things, bioequivalence study design to support ANDA submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” The document describes FDA’s intent to exercise enforcement discretion, for a limited time and in limited circumstances, on the requirement to
Devices
FDA has announced a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” FDA says the new version is intended to “further emphasize the importance of ensuring that devices are designed securely,
Drugs
FDA has approved Regeneron’s Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms. EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the esophagus, according to an FDA
Drugs
House Energy and Commerce Committee Republican leaders have asked FDA commissioner Robert Califf to answer questions about a growing trend for clinical trials to rely solely on enrollment of patients from a single country, particularly China, and the history of fabricated data in clinical trials conducted in China. The Republican
Drugs
FDA has published a draft guidance, Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification, indicating the agency’s intent to exercise enforcement discretion for a limited period and in limited circumstances to encourage dietary supplement firms to correct past failures to submit
Drugs
CDER Office of Pharmaceutical Quality (OPQ) director Michael Kopcha says the agency is moving toward drafting and implementing regulations on pharmaceutical advanced manufacturing technology. Speaking during a PharmTech Drug Solutions podcast, Kopcha said manufacturing advances have been slow to occur in the pharmaceutical industry due to company concerns about regulations.
Devices
CDRH has announced a new “510(k) Sterility Change Master File Pilot Program” that is intended to give interested companies that terminally sterilize single-use devices (sterilization providers) using certain sterilization methods a pathway to submit a master file for the Center’s review. “FDA will accept a master file
Drugs
FDA has published a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in preventing human drug product and biological product shortages. The document says RMPs can provide stakeholders with a framework to
FDA Policy/General
FDA principal deputy commissioner Janet Woodcock says FDA is working toward new efficiencies through an agency-wide enterprise approach to its business process, data, and technology management that will allow it to work more efficiently and optimize the use of the vast amount of data that is the foundation of
Devices
FDA has published an update to its 6/2021 safety communication about the Philips Respironics recalled ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. The update gives the latest information about Medical Device Reports associated with the breakdown of the polyester-based polyurethane foam
Devices
The International Society for Pharmaceutical Engineering (ISPE) says FDA should provide an implementation time of at least three years for a revised medical device Quality Management System regulation. In its comment letter, ISPE also says FDA should state that any standards referenced refer to the current FDA recognized version of
Drugs
Medical journals should beef up their transparency efforts regarding disclosures about the “relationships of authors to companies with financial interests related to topics they write about,” according to Public Citizen’s Health Research Group founder and senior advisor Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro. The
FDA Policy/General
FDA principal deputy commissioner Janet Woodcock has been assigned to five agency offices and two Centers to provide “strategic counsel and enterprise transformation support,” according to FDA commissioner Robert Califf, but drugs and biologics — the two human health areas that her previous experience as a physician has covered — are notably
Devices
Former FDA Digital Health Center of Excellence director Bakul Patel has joined Google Health and its parent company Alphabet as senior director for global health strategy and regulatory. In an online post, Patel says he is “looking forward to learning from the teams in health across Google and Alphabet and