Drugs
FDA has published a draft guidance, Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations, to assist sponsors of microdose radiopharmaceutical drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. The guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique
FDA Policy/General
Federal Register notice: FDA has extended until 9/20 the comment period for an 8/14 Federal Register notice requesting feedback about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. To view the notice, click here.
FDA Policy/General
Billy K. Groce (Knoxville, TN) has pleaded guilty in the U.S. District Court for Western Virginia to evading FDA veterinary drug regulations. According to a Department of Justice release, evidence showed that Groce operated a business that was created for the purpose of illegally circumventing the agency’s regulation
Drugs
FDA has accepted for review two Array BioPharma NDAs to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for treating patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The company says that FDA told it that based on a
Drugs
CDER director Janet Woodcock is scheduled to testify before a 9/13 House Energy and Commerce Subcommittee on Health about “Modernizing FDA’s Regulation of Over-the-Counter Drugs.” The hearing is intended to provide members an opportunity to better understand the current framework in place at the agency for
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.” The document outlines FDA’s recommendations and expectations for evaluating and reporting age, race, and ethnicity data in medical device clinical studies. The primary intent of
Drugs
FDA commissioner Scott Gottlieb says reviews of all orphan drug designation requests older than 120 days were completed 8/28, well ahead of the 9/21 deadline the agency had set for itself. The reviews were part of a comprehensive orphan drug modernization plan Gottlieb announced 6/29. Writing in
Drugs
Gilead is asking the 9th Circuit Court of Appeals to rehear or rehear en banc a whistleblower case involving three of the company’s HIV drugs that was initially thrown out by a California federal court. In its petition for a rehearing, Gilead says the whistleblowers’ complaint alleges that the
FDA Policy/General
Federal Register notice: FDA has announced a “Premarket Approval Application Critical to Quality” pilot program. Participation is voluntary and the program aims to evaluate device design and manufacturing process quality information early in the development process to assist FDA in its review of the PMA manufacturing section and post-approval
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dynavision International West Chester, OH (9/5): FDA inspected the firm in April and determined that its Dynavision D2 product is misbranded because there have been major changes or
Drugs
Researchers at the Oregon Health & Sciences University say that a majority of doctors on Twitter with significant financial conflict (at least $1,000 in general payments in 2014) and frequent tweets (at least 100 total tweets) mention specific drugs for which they have a conflict, and almost none disclose
Drugs
FDA continues to urge the adoption of continuous manufacturing (CM) by drug manufacturers. The agency is seeking comments until 9/21 on about the science, technology, and best practices concerning CM, says CDER Office of Pharmaceutical Quality director Michael Kopcha in an FDA Voice blog post. He notes that despite
Biologics
FDA has accepted for review an Adello Biologics BLA for a biosimilar candidate referencing Amgen’s Neupogen (filgrastim), indicated for treating neutropenia. Filgrastim is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells. The BLA submission is supported by similarity data from
Devices
FDA has issued a final guidance on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” that provides recommendations to improve data quality, consistency and transparency on how medical devices perform within specific age, race, and ethnic groups. “In general,” the guidance says, “to achieve
FDA Policy/General
Federal Register notice: FDA has announced a 10/4 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern hemisphere influenza season. To view the notice, click here.
Devices
FDA has announced a pilot program on “Approval Application Critical to Quality (PMA CtQ)” which aims to evaluate device design and manufacturing process quality information early in device development. The pilot is intended to provide qualifying PMA applicants with the option to engage FDA on developing CtQ controls and earn
Drugs
Galena Biopharma has agreed to pay the federal government more than $7.55 million to resolve allegations under the civil False Claims Act that it paid kickbacks to doctors to induce them to prescribe its fentanyl-based drug Abstral. The government contends that the company provided 85 free meals to
Drugs
Janssen Sciences has decided to discontinue development of its investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct-acting antivirals — AL-335, odalasvir and simeprevir. While ongoing Phase 2 studies with JNJ-4178 will be completed as planned, the decision to abandon the program is based on
Drugs
A top priority for FDA commissioner Scott Gottlieb is to modernize how clinical information is collected. “FDA continues to advance the use of new tools and clinical trial designs,” he said in an online post of a speech to stakeholders. “For example, we’re seeing wider use of adaptive approaches,
FDA Policy/General
FDA Seeks Comments on Reducing Regulation Burden Federal Register multiple notices: FDA seeks comments to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. 09/08/2017 Workshop on Self-collection Devices for Pap Testing Federal Register notice:
Drugs
FDA has issued Novartis a priority review voucher after approving qualifying rare disease product Kymriah (tisagenlecleucel), indicated for treating certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (see earlier story). As amended by the FDA Safety and Innovation Act, the agency awards priority review vouchers
FDA Policy/General
Federal Register multiple notices: As part of the Trump Administration’s “Reducing Regulation and Controlling Regulatory Costs” efforts, FDA is seeking comments to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction while allowing it to achieve its