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FDA has issued a draft guidance, Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders, with recommendations for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FDA has issued a draft guidance on “Information Requests and Discipline Review Letters Under GDUFA” that outlines how such letters will be used during the ANDA review process.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FDA has released a draft guidance on “Investigational IVD Used in Clinical Investigations of Therapeutic Products” to help researchers involved in precision medicine development determine if an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
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles” that intends to eliminate unnecessary burdens that may delay product marketing. It describes the guiding principles and recommended approach for FDA staff and industry to encourage a consistent application of least burdensome
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediatric disease product — Mepsevii (vestronidase alfa-vjbk), indicated for treating Mucopolysaccharidosis Type VII. To view the notice, click here.
FDA Policy/General
Federal Register correction notice: FDA is correcting an 11/27 notice entitled “Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop.” The date of the meeting has changed from 1/11/2018 to 3/8/2018. To view the notice, click here.
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
Devices
Medtronic has reached a $12 million settlement with five states to resolve allegations that it unlawfully promoted to doctors its Infuse bone graft device used in spinal fusion procedures. Oregon attorney general Ellen Rosenblum announced the settlement and said her state would receive $2.4 million. The other states participating
Devices
FDA has published a draft guidance, The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles, as required by Congress in the FDA Modernization Act of 1997 for medical device premarket evaluation.
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
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Prescription Drug Marketing Act of 1987 — Administrative Procedures, Policies, and Requirements, OMB Control Number 0910-0435.” Reporting and recordkeeping requirements found in FDA regulations are intended to: (1) Ban the reimportation of prescription drugs produced in the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) OMB Control Number 0910-0139.” The information collection requirements in GMP regulations provide FDA with the necessary information to perform its duty to
FDA Policy/General
Federal Register notice: FDA has announced a 3/19/18 public workshop entitled “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The workshop will discuss how interested parties might develop and submit proposed draft guidance on patient experience data for the agency’s
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
Devices
An updated FDA assessment of the use of laparoscopic power morcellators (LPMs) to treat uterine fibroids says the agency continues to caution against their use in the majority of women undergoing myomectomy or hysterectomy to treat fibroids. “While minimally invasive surgery conveys several advantages over open surgery for women with
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