Drugs
FDA has published a draft guidance, Information Requests and Discipline Review Letters under GDUFA, explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during review of an ANDA as contemplated in GDUFA 2. The document says the guidance does not
Drugs
FDA has approved La Jolla Pharmaceuticals’ Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. An FDA news release says that in a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded
Drugs
A 7/10-7/14/17 FDA inspection at Deserving Health International, Richmond, British Columbia, Canada, a manufacturer of sterile homeopathic eye drops, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. Specific violations cited in a 12/18/17 Warning Letter were: * failing to follow appropriate
Drugs
FDA says its review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A drug safety communication says that in 2011
Drugs
FDA is requiring a new class Warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for MRIs. The Warning concerns retention of gadolinium in patients’ bodies, including the brain, for months to years after receiving the drugs. “Gadolinium retention has not been directly linked to adverse health
Drugs
A 3/6-3/9/17 FDA inspection at Prosana Distribuciones SA de CV, Mexico City, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 12/18/17 Warning Letter says that specific violations were: * failing to have for each batch of drug product
Drugs
A 4/6-4/14/17 FDA inspection at Fresenius Kabi Oncology Limited, Hirnachal Pradesh, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 Warning Letter. The specific violation cited in the letter was failing to thoroughly investigate any
Drugs
FDA has issued a draft guidance, Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders, with recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or
Drugs
FDA has issued the latest CDER Data Standards Program Board action plan with a quarterly update for internal and external stakeholders on progress on current CDER data standards initiatives. The document says program initiatives are derived from the major areas of regulatory business activities — drug development and premarket review, drug
Drugs
CDER director Janet Woodcock says that the Center’s experience monitoring pharmacy compounding since passage of the Drug Quality and Security Act “has demonstrated a need for further improvement in compounding practices.” Writing in the New England Journal of Medicine, Woodcock says that the agency has discovered problematic conditions in
Drugs
Bloomberg News columnist Max Nisen says FDA commissioner Scott Gottlieb may not always be the friend the drug industry expected to see in the commissioner’s office. Nisen’s column says that Gottlieb is the only Trump administration official to follow through on the president’s rhetoric about high drug
Drugs
FDA has issued a draft guidance on “Information Requests and Discipline Review Letters Under GDUFA” that outlines how such letters will be used during the ANDA review process. The recently reauthorized generic drug user fee program calls for using the letters to provide “preliminary thoughts on possible deficiencies as each
Drugs
FDA is revising a listing that identifies brand drugs that do not have any generic competition. Key changes to the listing include presenting the information more clearly by drug product instead of by active ingredient to help firms identify products for potential development, an agency posting says. The list now
Drugs
FDA has released a draft guidance on “Investigational IVD Used in Clinical Investigations of Therapeutic Products” to help researchers involved in precision medicine development determine if an in vitro diagnostic (IVD) device used in a drug study will require a separate agency review from the drug being studied. The agency
Drugs
FDA has lifted a clinical hold on Alnylam Pharmaceuticals’ clinical studies with fitusiran, indicated for treating patients with hemophilia. Lifting the hold will allow trials to resume, including a Phase 2 open-label extension study and the ATLAS Phase 3 program, the company says. Alnylam company says it and the
Drugs
The Project On Government Oversight (POGO) is questioning how biotech executive John F. Crowley, who president Trump profiled as an example of speeding drug development in a February address to Congress, was able to advance a stalled experimental drug called migalastat to a fast track review at FDA. Crowley’s
Biologics
Results of a study led by FDA scientists suggest that a new technology known as high throughput sequencing (HTS) could be standardized and used for rapid screening of biologic products, including vaccines, to demonstrate absence of contamination. The technology reportedly enables scientists to sequence hundreds of millions of DNA molecules
Drugs
Continuing the Amgen-Sandoz debate over provisions of the Biologics Price Competition and Innovation Act (BPCIA), the Federal Circuit Court of Appeals has ruled that state claims against Sandoz sought by Amgen are preempted by federal law. The appeals court heard the case on remand from the Supreme Court, which
Drugs
FDA has just released the FDA-483 with five observations from a 1/7-1/23/14 inspection at Baxter Healthcare in Cleveland, OH. Specific observations on the form were: * the quality control unit lacks the responsibility and authority to reject all drug products; * control procedures are not established that
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The submission is based on data from the Phase 3 CheckMate-214 study, which was stopped early based on the
Drugs
FDA says it has created a Web site to provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. “This approach is intended to aid healthcare processionals in making more informed prescribing decisions that will both benefit their patients
Drugs
FDA has released the FDA-483 following an 11/20-11/30 inspection at Shilpa Medicare Limited, a sterile and non-sterile drug manufacturer in Telangana, India. Inspection observations shown on the form were: * redacted * scientific rationale could not be provided for some commercial product specifications; * procedures for the cleaning