Drugs
FDA has published a guidance, Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products, to describe the circumstances under which the agency generally does not intend to take action regarding required stability studies for the repackaged products and appropriate expiration dates under those circumstances. The document addresses
Drugs
FDA has published a draft guidance, Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in complying with the content and format requirements for human drug and biological products labeling subsections on pregnancy, lactation, and females and males of reproductive
Drugs
FDA has published a guidance, Pathological Complete Response in Neoadjuvant Treatment of High-Risk, Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval, to assist sponsors in designing trials to support marketing approval of drugs and biological products for treating high-risk early-stage breast cancer in
Drugs
The Department of Justice (DoJ) says Pacira Pharmaceuticals will pay $3.5 million to resolve allegations that it paid kickbacks to doctors as bogus research grants to induce them to prescribe its Exparel (bupivacaine liposome injectable suspension) non-opioid analgesic. A DoJ statement says the allegations arose from a False
Drugs
FDA has updated its inactive ingredient database (IID) that allows users to perform electronic queries to obtain accurate maximum daily exposure (MDE) information for excipients for each route of administration. “MDE is the total amount of the excipient that would be taken or used daily based on the maximum daily
Drugs
A Government Accountability Office (GAO) report says FDA officials believe that a new process for regulating over-the-counter drugs included in the CARES Act “could improve FDA’s ability to address identified safety risks in a more timely and efficient manner in the future.” GAO says the act “established
Drugs
In a letter to JAMA Internal Medicine published 7/27, CDER director Janet Woodcock and two of her Center colleagues defend the agency’s use of so-called integrated reviews from concerns that they won’t meet the agency’s goals and may introduce new problems. With the modernized reviews,
Drugs
FDA has posted a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document describes FDA’s recommendations for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two
Drugs
A 1/13-1/17 FDA inspection at Eosera, Inc., Fort Worth, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/13 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
An 11/12-11/25/19 FDA inspection at Tender Corp., Littleton, NH, found significant violations of current good manufacturing practice (CGMP) regulations in the firm’s production of over-the-counter unapproved and misbranded new drugs. A 7/23 Warning Letter says specific violations were: * failing to ensure that
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Eosera, Inc., Fort Worth, TX (7/13): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. For example, Eosera failed to thoroughly investigate any
Drugs
Indivior Solutions has pleaded guilty to one felony count and agreed to pay a total of $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment Suboxone (buprenorphine). An earlier $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group, and
Drugs
FDA is requesting additional data and manufacturing information from Solid Biosciences to potentially lift a clinical hold on the company’s Phase 1-2 IGNITE DMD clinical trial that is evaluating SGT-001 in Duchenne muscular dystrophy. The hold was originally placed 11/2019 after the company reported a serious
Drugs
FDA has approved an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease. Approval was based on data from the Phase 3 ETHOS trial that demonstrated Breztri Aerosphere had a statistically significant reduction in the rate of moderate or
Drugs
FDA has granted MyoKardia a breakthrough therapy designation for mavacamten, an oral, allosteric modulator of cardiac myosin for treating symptomatic, obstructive hypertrophic cardiomyopathy. In May, MyoKardia announced topline results from the pivotal Phase 3 EXPLORER clinical trial that showed mavacamten was well tolerated and has a safety profile comparable to
Drugs
FDA has granted Kite accelerated approval for Tecartus (brexucabtagene autoleucel), a chimeric antigen receptor T cell therapy for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL). Approval is based on results from ZUMA-2, a single-arm, open-label study in which 87% of patients responded to
Drugs
FDA has cleared a Palliare 510(k) for its EVA15 insufflator and smoke evacuation system. The device was designed to meet the “demanding insufflation requirements of endoscopic and robotic surgery, while offering integrated surgical smoke evacuation capability, filtering the hazardous smoke particles produced during laparoscopic surgery and removing them from
Drugs
Taro Pharmaceuticals has agreed to pay $205 million in criminal fines to resolve charges of conspiring to fix prices for generic drugs, according to the U.S. Justice Department. A two-count felony charge was filed in eastern Pennsylvania federal court that charged the company with participating in two criminal
Drugs
FDA is proposing a rule to establish requirements for the deadline and contents of an annual summary required from sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient under the Right to Try Act of 2017. The proposed rule says that under the law
Drugs
FDA has lifted its clinical holds on CymaBay Therapeutics’ seladelpar for its three IND applications for nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis. The company says it stopped all seladelpar clinical trials 11/25/19 after atypical histologic findings with no clinical or laboratory correlates were
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy. Approval was based on data from a global Phase 3 double-blind, placebo-controlled study in
Drugs
FDA has published tables summarizing the current number of drug development tool qualification projects, grouped overall by program and development tool stage. The document says the development tool stage is determined by the last submission accepted by the agency. The tables are updated and reported twice a year. The overall