Drugs
Members of the International Committee of Medical Journal Editors say they believe there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a statement published in JAMA, the editors say they remain committed to the goal of data
Drugs
Amgen’s suit against FDA over the agency’s denial of six months’ pediatric exclusivity for the company’s Sensipar (cinacalcet) tablets has been placed on hold by a DC federal court judge while the company seeks resolution of its claim through the FDA formal dispute resolution process. Attorney Kurt
Drugs
FDA says its review of Prestige Brand Holdings’ listings for PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s Plus Flu products contain inaccurate information. An agency 6/1 Warning Letter says the company must take prompt action to correct the deficiencies. According to the letter, the active
Drugs
A 5/23-5/26/16 FDA inspection at Yusef Manufacturing Laboratories found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/25 Warning Letter from the agency’s Los Angeles District Office. Specific violations noted in the letter were: * failing to thoroughly
Drugs
Acorda Therapeutics says it plans to file an NDA by the end of the month for CVT-301 (levodopa inhalation powder) after Phase 3 data showed a statistically significant, clinically meaningful improvement in motor function in Parkinson’s patients experiencing OFF periods. The company says OFF periods refer to the
Drugs
Two CDER staffers from the Office of Compliance and Office of Pharmaceutical Quality discussed the Center’s expectations for data integrity and compliance with CGMP at the Society of Quality Assurance annual meeting. They said that 2016 enforcement actions, not including compounding-related action, involved 47 import alerts, 4 Untitled
Drugs
CEL-SCI Corp. has responded to FDA about a clinical hold placed on the company’s Phase 3 head and neck cancer study with Multikine (leukocyte interleukin injection). The response addressed the study’s investigator brochure and a “Dear Investigator” letter, which were revised based on earlier FDA comments. The
Drugs
A just-concluded inspection of Strides Shasum Ltd. in Bangalore, India has resulted in a three-item Form-483 citing GMP deficiencies concerning finished pharmaceuticals. For example, the agency said the firm conducted manufacturing investigations but did not arrive at a root cause to take corrective actions. Additionally, FDA found
Drugs
Public Citizen and 12 other patient advocacy groups are urging House Energy and Commerce Committee members to reject two bills that would “undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.” In a 6/5 letter, the groups argue that HR
Drugs
A just-completed FDA inspection of Lupin Ltd.’s Madhya Pradesh, India manufacturing facility has resulted in a six-observation Form 483 related to GMP deviations at the plant. For example, agency investigators said the firm invalidated 96% of all the out-of-specification results obtained during testing of commercial
Drugs
OncBioMune Pharmaceuticals has submitted to FDA a Phase 2 clinical trial protocol for ProscaVax, a novel therapeutic cancer vaccine for early stage prostate cancer. In the trial, ProscaVax will be evaluated for safety, tolerability and efficacy as a treatment for patients with a new disease diagnosis and who have chosen
Drugs
FDA has cleared a GenePOC 510(k) for its GBS LB assay and its revogene instrument, a molecular diagnostic for identifying antepartum Group B Streptococcus colonization in newborns. Clearance was based on data from a clinical validation study that compared the assay to a standard culture. The assay used vaginal
Drugs
OncBioMune says it has submitted to FDA its protocol for an upcoming Phase 2 trial of ProscaVax as a novel therapeutic cancer vaccine for early-stage prostate cancer. The company says the trial will evaluate the agent for safety, tolerability, and effectiveness as a treatment for patients at disease presentation
Drugs
The HHS Office of Inspector General (OIG) says settlements were reached with a drug company and a durable medical equipment company during the six months ending 3/31. In a semi-annual report to Congress covering the period 10/1/16 to 3/31, the OIG says Shire entered into
Drugs
FDA has published the FDA-483 issued following a 4/17-5/10 agency inspection at Qualgen, Edmond, OK, an outsourcing facility. The five inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its
Drugs
National Institutes of Health (NIH) director Francis Collins says in an online agency blog post that the scope of the nation’s opioid crisis is staggering but not hopeless, and NIH has a plan to accelerate research in three critical areas. He says there is a need for: * additional overdose-
Drugs
FDA has released the FDA-483 issued following its 3/3-3/23 inspection at Fusion IV Pharmaceuticals, Los Angeles, CA, a producer of sterile drug products. Observations were: * failing to establish procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * · failing to have procedures designed
Drugs
FDA has approved a Nexus Pharmaceuticals ANDA for generic sodium nitroprusside injection, indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis. The product is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute
Drugs
FDA has approved multiple drug manufacturers’ ANDAs for the first generic versions of Eli Lilly’s Strattera (atomoxetine) for treating attention-deficit/hyperactivity disorder in pediatric and adult patients. Approvals were granted to Apotex, Teva Pharmaceuticals USA, Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited for multiple strengths of the drug
Drugs
A Lachman Consultants blog post says that both FDA and industry realize that the only real way to cut down on FDA’s ANDA review workload is to get it right the first time. “Industry continues to say with the constantly changing requirements and FDA expectations, it makes this very
Drugs
Ohio attorney general Mike DeWine has filed a state law suit against five leading prescription opioid manufacturers and their related companies in a county common pleas court in an area of the state that he says was likely the hardest hit place in the country for the opioid epidemic. The
Drugs
An AssurX blog post says that FDA “continues to expect major improvements in pharmaceutical manufacturing quality management. While it’s anyone’s guess, given today’s federal government budget debate, it still appears likely FDA will continue its focus on GMP and data integrity issues through 2017. If an FDA