JURIST
APRIL 27, 2023
The EU Wednesday released a draft of its proposed overhaul of drug manufacturing laws. The changes have caused controversy among manufacturers, with some stating they will leave the region if the laws take effect. However, the changes sparked some pushback from the drug manufacturing industry.
FDA Law Blog
FEBRUARY 13, 2025
The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA recommends including only a limited number of modifications in the PCCP.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
FDA Law Blog
NOVEMBER 6, 2023
Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. The guidance applies to facilities manufacturing human drugs, biologics, and veterinary medications, and to clinical trial sites for drugs.
FDA Law Blog
JULY 23, 2024
FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. A control strategy should be established to ensure that each lot of the final finished product is manufactured to conform to the design outputs.
FDA Law Blog
MAY 6, 2024
Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. are cybersecure.
FDA Law Blog
DECEMBER 3, 2023
As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.
Expert insights. Personalized for you.
197 
Let's personalize your content