FDA Law Blog
SEPTEMBER 6, 2023
Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. By Douglas B.
World of DTC Marketing
APRIL 12, 2021
The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Up to 90% of drugs now sold in the US and UK are generic.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Camargo
OCTOBER 14, 2021
The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation.
FDA Law Blog
MARCH 5, 2023
Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.
Pharmacy Checkers
MAY 22, 2020
PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.
Pharmaceutical Technology
NOVEMBER 21, 2022
Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.
Pharmaceutical Technology
NOVEMBER 21, 2022
Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.
Expert insights. Personalized for you.
45 
Let's personalize your content