FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Eli Lilly’s Tauvid (flortaucipir F–18), indicated for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Real-Time Oncology Review (RTOR).” The document provides recommendations to applicants on the process for submitting certain NDAs/BLAs with oncology indications for review under the review program. RTOR promotes earlier submission of topline results (i.e., efficacy and
Drugs
CDER director Patrizia Cavazzoni says the potential use of “circulating tumor DNA (ctDNA)” as a potential endpoint to support an accelerated approval is very promising, but it requires more data to validate the biomarker for further regulatory uses. Speaking at a 7/19 Friends of Cancer Research fireside chat on
Drugs
FDA has posted a final guidance entitled “Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.” The document provides recommendations on actions an ANDA applicant can take after the issuance of a complete response letter (CRL) as well as the actions that FDA may take if
Drugs
FDA has issued a final guidance entitled “Orange Book Questions and Answers” that answers commonly asked questions it has received from interested parties. It covers topics such as the content and format of the Orange Book, petitioned ANDAs, drug products moving between the Active and Discontinued sections, and drug product
Devices
FDA has posted an updated final guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database (GUDID) Requirements for Certain Devices” that outlines a 75-day extension of the agency’s expected compliance date. The document notes
Drugs
FDA has made available a proposed rule on Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351) that outlines the agency’s adoption of 12-digit format for national drug codes (NDCs). The agency says it is running out of 10-digit
Drugs
Three Syneos Health executives say there are six things FDA could do to better improve representation in clinical trials. Writing in a Stat News online opinion column, the three praise the agency’s guidances issued over the last 25 years and say the recent 4/2022 guidance is a welcome
Biologics
Keynoting the International Society for Pharmaceutical Engineering 2022 Biotechnology Conference, CBER director Peter Marks said regulatory pathways and review were not the biggest rate-limiting factor in Covid-19 vaccine development. Rather, he said, the real bottleneck was process development and manufacturing scaleup, as reported by Bioprocess Online. Under Operation
Drugs
Two women who worked as study coordinators at Florida’s Tellus Clinical Research have pleaded guilty to participating in a conspiracy to falsify clinical trial data. The Department of Justice says Analay Rico, Fort Lauderdale, and Daylen Diaz, Miami, reached a plea agreement in which they admitted agreeing with others
Devices
FDA has cleared a BioCircuit Technologies 510(k) for its nerve repair device, Nerve Tape, a sutureless option for surgical repair of transected nerves. The device is intended for use in peripheral nerve injuries, the company says. The biologic wrap with integrated microhooks is designed to “bind firmly, safely, and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — Dose Banding.” The document is intended to assist applicants in incorporating dose banding information into the drug labeling
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Evaluation of Therapeutic Equivalence.” The document explains how the agency evaluates generic drug therapeutic equivalence assignments for inclusion in its Orange Book. To view the notice, click here.
Devices
In its latest safety communication update on using a Renuvion/J-Plasma device for certain esthetic procedures, FDA says it cleared 7/15 the Renuvion APR Handpiece for use in subcutaneous dermatological and esthetic procedures to improve the appearance of lax skin in the neck and submental region. The update
Drugs
Michigan Gov. Gretchen Whitmer (D) is asking FDA commissioner Robert Califf to “remove the mifepristone Risk Evaluation and Mitigation Strategy (REMS) restrictions in order to eliminate yet another burdensome requirement that threatens timely and essential reproductive health care.” In a 7/21 letter, Whitmer says the REMS restrictions “are preventing
Devices
While the FDA user fee reauthorization has hit some roadblocks on Capitol Hill (see earlier story), the Advanced Medical Technology Association (AdvaMed) is urging the House and Senate to come to terms on a reauthorization package that includes diagnostic reform provisions that were approved by the Senate Health, Education, Labor
FDA Policy/General
Federal Register notice: FDA has announced a 9/22-23 Oncologic Drugs Advisory Committee meeting. On 9/22, panel members will discuss a Spectrum Pharmaceuticals NDA for poziotinib tablets, indicated for treating patients with previously treated, locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion
FDA Policy/General
Federal Register notice: FDA has determined that Fresenius Kabi’s Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due to safety or effectiveness issues. The determination allows FDA to approve ANDAs that reference the product as long as relevant legal and regulatory requirements are met. The product
Drugs
FDA has published a draft guidance, Evaluation of Therapeutic Equivalence, explaining the agency’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes. The document says FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under Section 505 of the Federal Food, Drug, and Cosmetic
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports the International Council for Harmonization (ICH) Q9(R1) draft guidance on quality risk management and recommends several revisions for clarity. “We support revision of the Q9 quality risk management guidance and FDA’s efforts to help facilitate more effective
Drugs
Former CDER staffer Jacqueline Major and colleagues at Harvard, the University of Pennsylvania, and the National Cancer Institute say the FDA Sentinel System’s electronic healthcare data may be useful for characterizing short latency cancer risk, examining cancer drug utilization and safety post-diagnosis, and conducting surveillance for acute adverse
Devices
FDA has classified as Class 1 a Smiths Medical recall of its Medfusion 3500 and 4000 Syringe Infusion Pumps due to eight software malfunctions. The malfunctions may cause serious harm or death to patients from under- or over-infusion, or delays in medication delivery, according to a recall notice. The