FDA Policy/General
Federal Register notice: FDA is announcing a “Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program” for foreign facilities manufacturing active pharmaceutical ingredients (APIs) that are used in FDA-regulated prescription and over-the-counter drug products. The purpose of the pilot is to gain insight from third-party assessments
FDA Policy/General
Federal Register notice: FDA is announcing its Quality Management Maturity for Finished Dosage Forms Pilot Program for domestic drug product manufacturers of prescription and over-the-counter drug products. The pilot is intended to gain insight from third-party assessments of a manufacturer’s quality management system to inform future
FDA Policy/General
Federal Register notice: FDA is announcing a requirement for electronic submissions to be submitted using the Electronic Common Technical Document Module 1 U.S. Regional DTD Version 3.3 beginning 3/1/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. The document provides the agency’s current thinking on technical considerations specific to devices using nitinol due to the unique properties of nitinol. It is also intended to provide
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. The document discusses the agency’s current thinking on the type of biocompatibility information that should be provided in a premarket submission for certain devices made from
FDA Policy/General
The Justice Department says Merit Medical Systems, South Jordan, UT, has agreed to pay $18 million to resolve allegations that it caused the submission of false claims to government healthcare programs by paying kickbacks to doctors and hospitals to induce use of its products. A department statement says the company
FDA Policy/General
Almost two months ago, FDA commissioner Stephen Hahn removed his newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 at an 8/23 White House press conference. It is now being discovered that Miller never left the
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on its Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee panels. The annual notice is intended to provide an opportunity for patients, representatives of patients, and medical device sponsors that may be the subject
FDA Policy/General
Taking advantage of a supportive audience at the Reagan Udall Foundation 10/13 annual meeting, FDA commissioner Stephen Hahn again reiterated the agency’s science-based decisions and avoidance of political pressure. “Of course, our work on Covid-19 and non-Covid issues comes with unprecedented public scrutiny,” Hahn said.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Haloderm, Carlsbad, CA (10/6) FDA recently reviewed the firm’s Web site and determined that it takes orders for products that are unapproved new drugs. The letter says
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” The meeting is intended to obtain early input from the public on a potential
FDA Policy/General
Final Guide on Biological Deviation Reporting Federal Register notice: FDA makes available a final guidance entitled “Biological Product Deviation Reporting for Blood and Plasma Establishments.” 10/9/2020 Info Collection on Device Inspection Feedback Federal Register notice: FDA sends to OMB an proposed information collection entitled “Requests for Nonbinding Feedback
FDA Policy/General
Mylan has signed an agreement with the Medicines Patent Pool (MPP) to expand access to chronic hepatitis C medicines in developing countries. The agreement licenses Mylan to produce and market a generic version of Bristol-Myers Squibb’s Daklinza (daclatasvir) Tablets, 30 mg and 60 mg, for distribution in 112
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 13 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of nine ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
The Government Accountability Office (GAO) says FDA should take additional steps to strengthen efforts to provide effective laboratory safety oversight. A GAO report says it examined FDA efforts since 2016 to improve safety in its laboratories that work with hazardous biological agents. An initial GAO report in 2016 made five
FDA Policy/General
Federal Register notice: FDA is correcting a notice that published in the 9/21 Federal Register announcing the withdrawal of a final guidance entitled Investigational COVID–19 Convalescent Plasma. The docket number is being corrected for the guidance that was withdrawn. To view the notice, click here.
FDA Policy/General
FDA chief counsel Stacy Cline Amin says the Covid-19 emergency has offered the agency an opportunity to set a new legal precedent that will “inspire a new era of compliance and enforcement for FDA.” Delivering the annual chief counsel’s address at the Food and Drug Law Institute’s
FDA Policy/General
[Editorial essay by David McFarland and Jim Dickinson] President Trump may have bent other federal agencies to his will, but FDA’s win 10/7 in getting the White House to back away (see earlier story) from threats to block a Covid-19 emergency use authorization (EUA) guidance showed that
FDA Policy/General
Federal Register notice: FDA has announced an 11/2 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review an Olas Pharma NDA for Hydexor, a fixed-dose combination oral tablet containing hydrocodone, acetaminophen, and promethazine, indicated
FDA Policy/General
FDA and Duke University’s Margolis Center for Health Policy are virtually holding 10/14 the 12th annual Sentinel Initiative public workshop. The national electronic system for medical product safety surveillance was mandated by the FDA Amendments Act to analyze drug safety data from multiple sources. “The virtual public workshop
FDA Policy/General
Commenting on the FDA Interim Hiring and Retention Assessment conducted by Booz Allen Hamilton, Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency needs to take immediate action if it is to make substantial progress on the PDUFA 6 and Biosimilar User Fee Act (BsUFA) 2 goals on FDA