Drugs
FDA has released the FDA-483 issued following an 8/13-8/28 inspection at Pharm D Solutions, a Houston, TX, outsourcing facility. The 16 observations on the form were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * the
Drugs
Neurelis has filed an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures. The proprietary formulation of diazepam incorporates a combination of a vitamin E-based solution
Drugs
The American Medical Association (AMA) says it “strongly supports accelerating and expanding regulatory action to increase pharmaceutical market competition and combat anti-competitive practices.” Responding to an FDA public hearing on competition and innovation in the biological products marketplace, the association says it strongly supports FDA efforts to ensure a
Drugs
AstraZeneca says an FDA draft guidance on use of liquids and/or soft foods as vehicles for drug administration “provides a useful framework for the selection and assessment of vehicles for alternative dosing” and is based on good scientific practice. The company cautions that although the guidance is applicable to
Drugs
While the pediatric exclusivity extension has generated new pediatric indications for several drugs, it also has led to substantial rewards to drug manufacturers. That’s the conclusion of a study of pediatric clinical trials reported in JAMA Internal Medicine. The study authors from Harvard Medical School and several academic medical
Drugs
Researchers from the Institute for Safe Medication Practices and several academic medical centers say that the cost of pivotal clinical trials required by FDA to provide substantial evidence of efficacy for new therapeutic agents increases if more patients are needed to document treatment benefit, if active drug comparators are used,
Drugs
A 2/26-3/1 FDA inspection at Wilson Medicine Co., Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/11 Warning Letter. Specific violations cited in the letter were: * failing to establish written procedures for production and process control
Drugs
FDA has released one draft and two final guidances relating to aspects of drug compounding. The draft guidance, Insanitary Conditions at Compounding Facilities, describes examples of insanitary conditions observed by FDA at drug compounding facilities. The document specifically addresses drugs, including biological products, produced by pharmacies, federal facilities, and outsourcing
Drugs
CDER Office of Process and Facilities branch chief Ying Zhang recently presented (see slides) common issues and deficiencies cited during pre‐approval drug inspections. Speaking at the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD 9/20, Zhang listed the deficiencies and they include: * Inconsistencies between facility
Drugs
In an amicus brief submitted to the Supreme Court, Washington Legal Foundation (WLF) says the court should decide that federal law preempts a state law failure-to-warn claim in cases where it can be shown that FDA rejected a drug manufacturer’s request to change its label to include
Drugs
CDER Division of Biometrics IV director Dionne Price says FDA will publish draft guidances and develop or revise relevant Manuals of Policies and Procedures, standard operating procedures, and/or review templates to support increasing use of complex innovative trial designs (CIDs). In a CDER Conversation, Price says the guidances will
Drugs
FDA has released one draft and two final guidances relating to aspects of drug compounding. The draft guidance, Insanitary Conditions at Compounding Facilities, describes examples of insanitary conditions observed by FDA at drug compounding facilities. The document specifically addresses drugs, including biological products, produced by pharmacies, federal facilities, and outsourcing
Drugs
FDA has released a final guidance entitled “ANDA Submissions — Content and Format” that details the information that should be provided in each section of the common technical document format. The document also identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission. Additionally,
Drugs
In recognition of recent court decisions that have been protective of off-label promotion, CDER director Janet Woodcock has acknowledged that the pendulum has swung away from aggressive FDA drug advertising and promotion enforcement. Addressing an Alliance for a Stronger FDA gathering in Washington, DC 9/21, Woodcock was asked
Drugs
CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent director for the Office of New Drugs (OND). Woodcock has been overseeing OND since former director John Jenkins retired 1/2017. His departure became controversial after he made it clear that
Drugs
FDA has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical products for patients with rare diseases. The funding helps support early-stage development activities targeting rare diseases that don’t have effective treatments. “By providing seed capital,
Biologics
FDA has lifted a clinical hold against Sarepta Therapeutics against the company’s Duchenne muscular dystrophy micro-dystrophin gene therapy program. The hold was placed in July due to the presence of trace amounts of DNA fragment in research-grade third-party supplied plasmid in a manufacturing lot. “In response,
Drugs
FDA has approved Cook Medical’s new 5 mm diameter version of Zilver PTX, described by the company as the first 5 mm peripheral artery disease drug-eluting stent in the U.S. with lengths available up to 140 mm that is indicated to treat vessels as small as 4mm
Drugs
Joint Panel to Review Alkermes Depression NDA Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive disorder. 09/21/2018 Draft Guide on Clinicaltrials.com Money Penalties Federal Register notice: FDA makes available a draft guidance entitled “Civil Money
Drugs
Eli Lilly has agreed to acquire AurKa Pharma, a company established by TVM Capital Life Science to develop oncology compound AK-01, an Aurora kinase A inhibitor that was originally discovered at Lilly. The potential first-in-class drug is being studied in Phase 1 clinical trials in multiple types
Drugs
The FDA has charged A & O Enterprises (dba iV Bars), a seller of intravenously injected therapy products (iV Cocktails), with making a range of deceptive and unsupported health claims about their ability to treat serious diseases such as cancer, multiple sclerosis, and congestive heart failure. This is the first
Drugs
FDA has approved a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 years and older. The device uses a small amount of a patient’s own skin to prepare “spray-on skin cells” at the point of care in as