FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Puma Bio’s Nerlynx (neratinib), indicated for extended adjuvant treatment of adult patients with early stage HER2- overexpressed/amplified breast cancer. The review period was 5,102 days, which includes 4,738 days that occurred
FDA Policy/General
FDA acting commissioner Ned Sharpless may be on the out as President Trump has not nominated him to be the permanent agency head, and under the Federal Vacancies Reform Act of 1998 he can only serve in a Senate-confirmed position for a maximum of 210 days, which would give
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) posted 8/12 an on-demand Webinar discussing elements of the 6/24 final guidance on providing promotional labeling and advertising materials in electronic and non-electronic format. OPDP lead project manager Jason Cober discussed the 24-month transition period for promotional
FDA Policy/General
Federal Register notice: FDA has extended the submission period related to a 6/29 notice on “Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program.” Submissions are now being accepted until 12/30. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.” The document finalizes an 8/24 draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a 3/1 notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations
FDA Policy/General
Attorney Anne Walsh (Hyman, Phelps & McNamara) says a recent Supreme Court decision “significantly cabined the scope and application” of what is known as the Auer deference, which requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. Writing in her firm’s FDA
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Male Breast Cancer: Developing Drugs for Treatment.” The document provides recommendations on the development and labeling of cancer drugs for treating male patients with breast cancer. It also provides recommendations on clinical development when males have either not been
FDA Policy/General
Federal Register notice: FDA has announced a 10/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs from CBER’s Laboratory of Hepatitis Viruses and the Laboratory of Vector-Borne Viral Diseases. They will also discuss and make
FDA Policy/General
A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction drug Stendra (avanafil) tablets. CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer print ad and display banners make false or misleading claims about the risks associated with the drug.
FDA Policy/General
Panel to Discuss Chikungunya Vaccine Development Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine development. 08/23/2019 Correction on Opioids Hearing Federal Register notice correction: FDA corrects a 6/21 notice entitled “Standards for Future Opioid Analgesic
FDA Policy/General
Janssen R&D Ireland has entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) and ViiV’s integrase inhibitor Tivicay (dolutegravir) as the sole active ingredients for the maintenance treatment of patients
FDA Policy/General
DEVICES FDA has cleared a CorMatrix Cardiovascular 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices including pacemakers and implantable cardioverter defibrillators. The device acts as a pouch to securely hold a cardiac implantable electronic device to create a stable environment when implanted in
FDA Policy/General
Federal Register notice: FDA has announced an 11/8 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on developing chikungunya vaccines. Chikungunya is an infection caused by the chikungunya virus, which is spread by mosquitos. To view the notice, click here.
FDA Policy/General
FDA principal deputy commissioner Amy Abernathy says the agency “supports the smart, secure, and safe interaction among different medical devices and information systems, and has been collaborating with hospitals, healthcare providers, standards development organizations, and other interested parties to promote medical device interoperability.” Speaking 8/22 at the National Coordinator
FDA Policy/General
Federal Register notice correction: FDA is correcting a 6/21 notice entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing.” That notice was published with incorrect presenter registration and slide deck submission deadlines. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Sunovion Pharmaceuticals’ Zonegran (zonisamide) capsules, 50mg, were not withdrawn for safety or effectiveness reasons. The determination means that FDA will continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. The drug is indicated
FDA Policy/General
The HHS Office of Inspector General (OIG) says FDA failed to submit an OIG clearance document for any of the 166 audit recommendations during FY 2016 and 2016. As a result, an OIG report says, all 166 were outstanding and listed on the stewardship report as past due for resolution
FDA Policy/General
Federal Register notice: FDA has announced a 9/26 joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets. They will also discuss pediatric data considerations for opioid analgesics
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Prescription Drug Product Labeling; Medication Guide Requirements” (OMB Control Number 0910–0393). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions 21 CFR part 60” (OMB Control Number 0910-0233). The collection supports agency regulations under the authority of the Drug Price Competition and Patent Term
FDA Policy/General
Federal Register notice: FDA has announced a 10/16 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to review a Shionogi NDA for cefiderocol lyophilized powder for intravenous administration, indicated for treating complicated urinary tract infections, including pyelonephritis due to gram-negative bacteria in patients with limited or no