Devices
Attorneys Aaron Josephson and Benjamin Zegarelli (Mintz) say in an online post that 2020 was the year that Americans became familiar with lesser-known and niche FDA policies like those governing emergency use authorizations, and with the agency role in regulating laboratory-developed tests. The two use this post to
Drugs
Parenteral Technologies is petitioning FDA to amend the children’s over-the-counter dosage schedule and directions of single-ingredient acetaminophen for ages 2-4 as published in the 11/16/88 tentative final monograph. The 11/21 petition also asks the agency to publish a statement of enforcement policy
Devices
Penumbra has recalled all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to a risk of unexpected death or serious injury while used for removing clots in stroke patients. All users should stop using this device, and facilities should remove the
Drugs
FDA is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. An agency statement says FDA purchased the products on Amazon and eBay and then tested them. It reports finding that
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. The document discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback
Drugs
FDA has approved MacroGenic’s Margenza (margetuximab-cmkb), in combination with chemotherapy, to treat adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. A company statement says Margenza is the first HER2-
Drugs
FDA has accepted for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus. The NDA is based on data from the pivotal Phase 3 trials ORBIT1 and ORBIT2, which investigated the safety
Biologics
Two university professors say it appears FDA assigned too few reviewers to key elements of the Pfizer/BioNTech Covid-19 vaccine application, possibly as a way to stifle internal dissent. Writing in an online Stat opinion column, University of Maryland School of Pharmacy associate professor Peter Doshi and Dalhousie University
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee voted 12/17 to recommend an Emergency Use Authorization (EUA) for Moderna’s investigational Covid-19 vaccine (mRNA-1273). Panel members voted 20 to 0 that the totality of available scientific evidence demonstrated that the vaccine’s benefits outweigh its risks
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “State Enforcement Notifications — 21 CFR 100.2(d)” (OMB Control Number 0910-0275). The collection supports Section 310(b) of the Federal Food, Drug, and Cosmetic Act that authorizes a state to enforce certain sections of the
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Rhythm Pharmaceuticals related to its rare pediatric disease product NDA for Imcivree (setmelanotide) injection, indicated for treating chronic weight management in adult and pediatric patients six years of age and older with proopiomelanocortin, proprotein convertase subtilisin/
Drugs
FDA has published a guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit controlled correspondence to FDFa requesting information related to generic drug development. The document also describes the agency's process
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Eiger BioPharmaceuticals that is related to its rare pediatric disease product NDA for Zokinvy (lonafarnib), indicated in patients 12 months of age and older to reduce the risk of mortality in Hutchinson-Gilford progeria syndrome. To
Drugs
Members of the FDA Cardiovascular and Renal Drugs Advisory Committee has voted 12-1 that Novartis’ Entresto (sacubitril/valsartan) is worthy of an expanded indication to treat heart failure with preserved ejection fraction, even though a trial designed to prove efficacy for this patient group narrowly missed the mark. The
Devices
FDA has granted a de novo marketing authorization for Miach Orthopedics’ anterior cruciate ligament (ACL) implant for ACL reconstruction to treat ACL tears. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to traditional reconstruction and does not require the use of harvested tendons for ACL repair. The device
Devices
FDA has issued Abbott an Emergency Use Authorization (EUA) for its “virtually guided” at-home use BinaxNOW Covid-19 Ag Card rapid test for detecting Covid-19 infection. Abbott is partnering with digital health solutions provider eMed to deliver and administer 30 million BinaxNOW at-home tests in the first
Drugs
A YourEncore white paper says that although a data strategy is critical to the successful completion of clinical trials, only one-third of companies responding to a survey said they had such a strategy. “Each company should invest the time and resources to develop a comprehensive strategy,” the paper says.
Drugs
Sens. Chuck Grassley (R-IA) and Ron Wyden (D-OR) have released a report identifying $65 million in payments made by manufacturers of opioids and opioid-related products to groups focused on pain issues. In a statement (contains a link to the full report), the senators say the opioid manufacturers
Drugs
FDA has released the FDA-483 containing 15 observations issued following a 10/13-10/29 inspection at Advanced Nutriceuticals, an Indianapolis, IN, producer of sterile drug products. The inspection observations were: * performing aseptic processing outside of a certified ISO 5 area; * the ISO classified aseptic processing area was located
Devices
EMD Serono says the FDA discussion paper “Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework” captures appropriate elements that should be considered. The company letter gives comments on sections of the FDA paper that could help to strengthen or clarify the text. The sections include “Interpretability: Make it Easy
Biologics
Federal officials told a 10/16 news media call that Pfizer has experienced some unexpected issues in rolling out its Covid-19 vaccine. They reported that at least two trays of vaccine doses delivered to California had to be replaced after their storage temperatures fell below manufacturer requirements, Reuters reports.
Drugs
Gilead Sciences and Galapagos are scrapping the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis (RA) after a recent meeting with FDA to discuss an 8/18 NDA complete response letter over testicular toxicity concerns. FDA told the companies that “substantial additional clinical studies” would be required to support