Drugs
FDA has released a 32-page FDA-483 issued following a 3/27-4/3 inspection at Hospira Healthcare India, Tamil Nadu, India. The 11 observations in the report were: * failing to follow responsibilities and procedures applicable to the quality control unit; * failing to have laboratory records include complete data
Drugs
FDA commissioner Scott Gottlieb says the agency plans to take a broader effort to help the drug industry to convert to more innovative and efficient manufacturing technologies. Advanced manufacturing, which includes continuous manufacturing and 3D printing, provide promising opportunities to improve the market for drugs and biologics, he said in
Drugs
FDA commissioner Scott Gottlieb says a new Drug Shortages Task Force will “delve more deeply into the reasons why some shortages remain a persistent challenge. The charge to this new task force is to look for holistic solutions to address the underlying causes for these shortages.” The commissioner’s statement
Drugs
FDA says criminals are forging Warning Letters targeting individuals who try to purchase medicines online or over the telephone. An agency news release says FDA is concerned that the fake Warning Letters are linked to an international extortion scam. “FDA generally does not issue Warning Letters to individuals who purchase
Drugs
FDA has posted a draft guide from the International Council for Harmonization on “Elemental Impurities Q3D(R1).” The document discusses cadmium and how it has been shown to be genotoxic, but not mutagenic and has been acknowledged as a human carcinogen. Also, positive associations have been observed between exposure to
Drugs
FDA has posted a draft guidance entitled “Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.” The document is intended to clarify the recommended approach for sponsors developing such drugs. “Sponsors have approached FDA to discuss development programs for drugs intended to treat resistant
Drugs
FDA has granted Acceleron Pharma an orphan drug designation for ACE-083, the company’s locally acting myostatin+ muscle agent, for treating patients with facioscapulohumeral muscular dystrophy (FSHD). The designation was based on positive preliminary data from an ongoing Phase 2 trial in patients with FSHD, according to the company.
Drugs
AbbVie has submitted a supplemental NDA for venetoclax in combination with a hypomethylating agent or in combination with low-dose cytarabine for treating newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The submission is based on investigational data from two studies: M14-358, a
Drugs
In 12 years on the DC Court of Appeals, Supreme Court nominee Brett Kavanaugh has helped decide some cases in favor of FDA, while ruling against the agency in others. A Stat News analysis reports that Kavanaugh was part of an 8-2 majority when the appeals court upheld a
Drugs
An FDA pooled study of five registration trials of cyclin-dependent kinases 4/6 (CDK4/6) found that all subgroups of patients with estrogen receptor-positive HER2-negative metastatic breast cancer benefited from the addition of the kinases to endocrine therapy. An ASCOPost online story says the study results were
Drugs
FDA has published three new draft guidances on development of gene therapy products for specific diseases. The agency also has released new and comprehensive updates to three existing guidances that address manufacturing issues related to gene therapy. A statement from FDA commissioner Scott Gottlieb (includes links to all six guidances)
Drugs
The Department of Justice has launched a Task Force on Market Integrity and Consumer Fraud authorized under an Executive Order signed by President Trump to focus on combating fraud against consumers — particularly the elderly, service members, and veterans — and corporate fraud that victimizes the general public and the government. Deputy
Drugs
AbbVie says it supports the FDA establishment of a public docket to assist with development of a guidance document on assessment of drug-drug interactions (DDI) for therapeutic proteins (TP). It recommends that characterization of DDIs for TPs be conducted clinically. It says that exceptions to this recommendation should only
Drugs
A Niskanen Center white paper says that over the years, FDA “has strayed from its mission by mandating clinical trials that require far more than evidence of safety and effectiveness.” The paper says this mission shift, which Congress has allowed to happen, has increased drug development times, costs, and prices.
Drugs
FDA is requiring safety labeling changes for fluoroquinolone antibiotics to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances, and to make the warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection. An agency news release
Drugs
A 9/11-9/15/17 FDA inspection at Zhuhai United Laboratories, Zhuhai, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/27 Warning Letter says specific deviations were: * failing to adequately investigate and document out-of-specification results according to a
Drugs
FDA has issued a draft guidance, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention, to assist sponsors in clinical development of drugs for treating or preventing smallpox infection. “Clinical efficacy trials of drugs for the treatment or prevention of smallpox are not feasible,” the document says, “and challenge
Drugs
FDA has released the FDA-483 issued following a 5/29-6/19 FDA inspection at Stokes Healthcare, a Mount Laurel, NC, outsourcing facility. Specific inspection observations were: * testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and
Drugs
Four drug industry stakeholders have provided detailed responses to an FDA request for comments on exposure-analysis in drug development and regulatory decision making. Pfizer suggests that the updated exposure-response guidance primarily focus on “what” and “why” elements and advance the 2003 version by citing illustrative examples that have
Drugs
President Trump has his sights on the drug industry after the latest round of price increases on dozens of products. In a 7/9 tweet, the president said: “Pfizer & others should be ashamed that they have raised drug prices for no reason. They are merely taking advantage of the
Drugs
FDA has published a draft guidance, Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products—Content and Format, to assist applicants in drafting the Indications and Usage section of labeling for human prescription drug and biological products. The document’s recommendations include general principles to consider
Drugs
The 6th Circuit Court of Appeals says a lawsuit alleging failure of a generic drug company to provide a Medication Guide with a prescription for the anti-arrythmia drug amiodarone is preempted by federal law. Attorney Michelle Yeary (Reed Smith) writes in an online blog post that this was the